OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

Boston Scientific Cork, Ltd. recalls 41 products

Recall date · record updated Oct 28, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Boston Scientific Cork, Ltd.
Reason
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99906…

Products (41)

  1. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number: M001195200

    Codes/lots: Material Number: M001195200; UDI-DI: 08714729839316; Batch Numbers: 37942457, 37999053, 38224527, 38304916, 38415911, 38687159, 38707977, 38916519, 39029416, 39029419, 39029640, 39092278, 40476286, 40479386, 40523958, 40525677;Quantity: 126Recall no. Z-0223-2027Class II

  2. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number: M001195210

    Codes/lots: Material Number: M001195210; UDI-DI: 08714729839323; Batch Numbers: 37914435, 37914436, 37956674, 37981343, 37981344, 38022632, 38022633, 38022634, 38149673, 38181211, 38224528, 38259475, 38259476, 38290713, 38290714, 38290715, 38290716, 38290717, 38399232, 38446223, 38479515, 38506196, 38530446, 38530447, 38629332, 38629333, 38647617, 38647618, 38649501, 38649508, 38687327, 38708440, 38708441, 38745184, 38769513, 38769514, 38934430, 39189795, 39189798, 40466471, 40466472, 40482683, 40482684, 40482685, 40487838, 40487839, 40487900, 40487954, 40487955, 40487956, 40487957, 40501048, 40501049, 40Quantity: 2547Recall no. Z-0224-2027Class II

  3. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155; Material Number: M001195220

    Codes/lots: Material Number: M001195220; UDI-DI: 08714729839330; Batch Numbers: 37981345, 38022666, 38629565, 38629566, 38708453, 38745192, 38800928, 38800929, 38916517, 38937262, 38990881, 39074440, 39141261, 40482690, 40482691, 40485783, 40485784, 40489060, 40507284, 40510556, 40512867, 40512868, 40512869, 40512993, 40512994, 40512995, 40513031, 40513032, 40539143, 40539144;Quantity: 459Recall no. Z-0225-2027Class II

  4. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number: M001195230

    Codes/lots: Material Number: M001195230; UDI-DI: 08714729839347; Batch Numbers: 37818205, 37942458, 37956675, 37981346, 38002441, 38224529, 38224530, 38304917, 38304918, 38415912, 38484288, 38506191, 38595896, 38629330, 38647611, 38647613, 38687220, 38687221, 38707976, 38876166, 38970274, 38970936, 39092279, 39092680, 40484896, 40484897, 40484952, 40523918, 40523919, 40525673, 40525674, 40525675, 40525676, 40531394, 40531395, 40531396;Quantity: 689Recall no. Z-0226-2027Class II

  5. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240

    Codes/lots: Material Number: M001195240; UDI-DI: 08714729839354; Batch Numbers: 37818206, 37818207, 37818208, 37818209, 37849382, 37849383, 37849384, 37849385, 37849386, 37849387, 37849388, 37849389, 37914437, 37914438, 37914439, 37914460, 37914461, 37956676, 37956677, 37981347, 38002442, 38022635, 38022636, 38049174, 38112465, 38112466, 38112467, 38112468, 38112469, 38149674, 38149675, 38149676, 38181212, 38181213, 38181214, 38224531, 38224532, 38224533, 38224534, 38259477, 38259478, 38259479, 38290718, 38290719, 38290720, 38290721, 38290722, 38290723, 38350139, 38350320, 38350321, 38350322, 38350323, 38Quantity: 8542Recall no. Z-0227-2027Class II

  6. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155; Material Number: M001195250

    Codes/lots: Material Number: M001195250; UDI-DI: 08714729839361; Batch Numbers: 37886785, 37981348, 38022667, 38022668, 38049175, 38149678, 38224535, 38259480, 38259481, 38323413, 38446235, 38506483, 38560459, 38560740, 38560741, 38595642, 38595643, 38644774, 38708452, 38745193, 38810251, 38904563, 38904564, 38937261, 38990880, 39027325, 39027326, 39092681, 39092682, 39140994, 39140995, 39141262, 39141263, 40482688, 40482689, 40502253, 40507285, 40512991, 40512992, 40525712, 40531379, 40537145;Quantity: 1292Recall no. Z-0228-2027Class II

  7. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260

    Codes/lots: Material Number: M001195260; UDI-DI: 08714729839378; Batch Numbers: 37818211, 37881104, 37942459, 38002443, 38224536, 38415913, 38595894, 38595895, 38629331, 38687224, 38904567, 38904568, 38916620, 38970937, 38990576, 38990842, 39027322;Quantity: 358Recall no. Z-0229-2027Class II

  8. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270

    Codes/lots: Material Number: M001195270; UDI-DI: 08714729839385; Batch Numbers: 37914462, 37956678, 38079823, 38079827, 38079828, 38181215, 38224537, 38290724, 38399239, 38399240, 38399241, 38446224, 38460466, 38479514, 38479518, 38506192, 38506193, 38527327, 38527328, 38560748, 38560749, 38560750, 38560751, 38629561, 38647619, 38649500, 38649513, 38769494, 38769500, 38827706, 38990346, 38990347, 39074447, 39191592, 40476394, 40482557, 40487835, 40487836, 40507432, 40513948, 40521921, 40521922, 40524021, 40524022, 40533341, 40535977, 40539682;Quantity: 1912Recall no. Z-0230-2027Class II

  9. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280

    Codes/lots: Material Number: M001195280; UDI-DI: 08714729839392; Batch Numbers: 38149679, 38323401, 38444072, 38506482, 38506491, 38560458, 38595645, 38810252, 38936816, 39140997, 39141264, 39189785, 39189791, 40482687, 40493382, 40512909;Quantity: 381Recall no. Z-0231-2027Class II

  10. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290

    Codes/lots: Material Number: M001195290; UDI-DI: 08714729839408; Batch Numbers: 38362172, 38362173, 38530450, 38595659;Quantity: 42Recall no. Z-0232-2027Class II

  11. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300

    Codes/lots: Material Number: M001195300; UDI-DI: 08714729839415; Batch Numbers: 37818213, 37818214, 37818215, 37818216, 37881115, 37886786, 37886787, 37886788, 37914463, 37914464, 37914465, 37943140, 37956679, 37957740, 37977611, 38002444, 38002445, 38085044, 38089225, 38092404, 38092405, 38092406, 38112470, 38112471, 38112472, 38149820, 38181217, 38191752, 38220950, 38330637, 38330638, 38415914, 38415915, 38444073, 38444074, 38484290, 38527320, 38527321, 38560452, 38573062, 38573063, 38585014, 38596980, 38596981, 38629571, 38629572, 38769972, 38769973, 38827700, 38827701, 38827702, 38827703, 38827704, 38Quantity: 3284Recall no. Z-0233-2027Class II

  12. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155; Material Number: M001195310

    Codes/lots: Material Number: M001195310; UDI-DI: 08714729839422; Batch Numbers: 37818217, 37818218, 37818219, 37881110, 37881111, 37881112, 37886789, 37886790, 37886791, 37886792, 37928860, 37928862, 38585015, 38585016, 38745481, 38745482, 38745483, 39143525, 39143526, 39143527, 40466594, 40466595, 40466596, 40476306, 40476307, 40476308, 40482692, 40482693, 40482694, 40485789, 40485790, 40485791;Quantity: 486Recall no. Z-0234-2027Class II

  13. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130; Material Number: M001195320

    Codes/lots: Material Number: M001195320; UDI-DI: 08714729839439; Batch Numbers: 37818440, 37818441, 37981349, 38002446, 38200316, 38200317, 38224539, 38304087, 38330639, 38399242, 38399243, 38503335, 38530451, 38629573, 38629576, 38650063, 38650068, 38810584, 38904811, 40466632, 40466633, 40466634, 40476310, 40476442, 40476443, 40482607, 40482609, 40489044, 40491252, 40493253, 40493444, 40502171, 40502326, 40502327, 40504735, 40504736, 40504737, 40525535, 40531443, 40531445, 40533244, 40533305;Quantity: 632Recall no. Z-0235-2027Class II

  14. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155; Material Number: M001195330

    Codes/lots: Material Number: M001195330; UDI-DI: 08714729839446; Batch Numbers: 37957742, 38361997, 38361998, 38439368, 38527323, 38527324, 38527326, 38876179, 38916511, 39029983, 39029986, 39092697;Quantity: 206Recall no. Z-0236-2027Class II

  15. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340

    Codes/lots: Material Number: M001195340; UDI-DI: 08714729839453; Batch Numbers: 37818442, 38181218, 38181219, 38224580, 38240231, 38350326, 38361999, 38460468, 38484291, 38503334, 38530454, 38530455, 38629574, 38650064, 38745484, 38769974, 38769975, 38904812, 38904813, 38937271, 38937272, 38990884, 39092686, 39092687, 40476309, 40476444, 40482608, 40507288, 40510453, 40525536, 40525537;Quantity: 748Recall no. Z-0237-2027Class II

  16. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155; Material Number: M001195350

    Codes/lots: Material Number: M001195350; UDI-DI: 08714729839460; Batch Numbers: 37881102, 37881103, 37943142, 37943143, 37957743, 38439681, 38439682, 38484292, 38527325, 38876320, 38904816, 38904817, 38916510, 38916512, 38990272, 38990273, 38990274, 39029898, 39092695, 39092696;Quantity: 384Recall no. Z-0238-2027Class II

  17. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105; Material Number: M001195400

    Codes/lots: Material Number: M001195400; UDI-DI: 08714729839477; Batch Numbers: 38049178, 38415916, 38595648, 38708403, 39141268;Quantity: 39Recall no. Z-0239-2027Class II

  18. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130; Material Number: M001195410

    Codes/lots: Material Number: M001195410; UDI-DI: 08714729839484; Batch Numbers: 38061296, 38092407, 38092408, 38112473, 38149821, 38181960, 38198831, 38224581, 38259482, 38273746, 38362200, 38362201, 38399244, 38445017, 38649517, 38649853, 38667794, 38810594, 38904807, 40470780, 40476390, 40482606, 40493383, 40495046, 40495047, 40495048, 40495049, 40502037, 40502268, 40510553, 40510554, 40512596, 40512597, 40512990, 40516627, 40518479, 40518820, 40518821, 40525714, 40525715, 40525716;Quantity: 902Recall no. Z-0240-2027Class II

  19. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155; Material Number: M001195420

    Codes/lots: Material Number: M001195420; UDI-DI: 08714729839491; Batch Numbers: 38049561, 38065517, 38092409, 38745199, 38745480, 39092274, 40482626, 40482629, 40497899, 40497980, 40502330, 40504597, 40504598, 40531426;Quantity: 228Recall no. Z-0241-2027Class II

  20. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105; Material Number: M001195430

    Codes/lots: Material Number: M001195430; UDI-DI: 08714729839507; Batch Numbers: 38149822, 38210076, 38415917, 38595649, 38708406, 39141265;Quantity: 76Recall no. Z-0242-2027Class II

  21. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440

    Codes/lots: Material Number: M001195440; UDI-DI: 08714729839514; Batch Numbers: 38181961, 38198832, 38224582, 38259483, 38324070, 38460469, 38560455, 38560456, 38595654, 38649857, 38745194, 38745195, 38810586, 38810591, 38904805, 39092267, 39092272, 39143222, 40470259, 40478976, 40478977, 40492318, 40497671, 40497858, 40502038, 40502039;Quantity: 620Recall no. Z-0243-2027Class II

  22. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155; Material Number: M001195450

    Codes/lots: Material Number: M001195450; UDI-DI: 08714729839521; Batch Numbers: 38224583, 38273637, 38649877, 38707975, 38745198, 40470668, 40470669, 40476288, 40476289, 40476304, 40476305, 40495080, 40504684, 40512595, 40516625, 40516626, 40523967, 40525596, 40531425;Quantity: 357Recall no. Z-0244-2027Class II

  23. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130; Material Number: M001195470

    Codes/lots: Material Number: M001195470; UDI-DI: 08714729839545; Batch Numbers: 38112474, 38149823, 38181962, 38181963, 38399282, 38415919, 38416360, 38445015, 38649840, 38649849, 39143221, 40470762, 40470763, 40470782, 40476387, 40476388, 40478984, 40478985, 40502172;Quantity: 382Recall no. Z-0245-2027Class II

  24. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480

    Codes/lots: Material Number: M001195480; UDI-DI: 08714729839552; Batch Numbers: 38649876, 38668791, 39074172, 39074173, 40482627, 40482628;Quantity: 45Recall no. Z-0246-2027Class II

  25. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500

    Codes/lots: Material Number: M001195500; UDI-DI: 08714729839576; Batch Numbers: 38061298, 38061299, 38092411, 38092412, 38092413, 38112475, 38112476, 38112477, 38167702, 38167705, 38181964, 38181965, 38181966, 38181967, 38181968, 38416361, 38416362, 38595650, 38595651, 38595652, 38650001, 38650003, 38746409, 38746410, 38810247, 38810248, 38904814, 38904815, 38937266, 38937267, 38937268, 38937270, 38990858, 39027320, 39092275, 39092276, 39092277, 40466592, 40466593, 40471963, 40471964, 40478978, 40478979, 40502334, 40502335, 40504653, 40504654, 40513028, 40513029, 40513030, 40524000;Quantity: 1349Recall no. Z-0247-2027Class II

  26. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number: M001195510

    Codes/lots: Material Number: M001195510; UDI-DI: 08714729839583; Batch Numbers: 38061601, 38063600, 38434622, 38434623, 38650006, 38650007, 40482630, 40482631, 40502273, 40502274;Quantity: 112Recall no. Z-0248-2027Class II

  27. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610

    Codes/lots: Material Number: M001195610; UDI-DI: 08714729839606; Batch Numbers: 37775581, 37914469, 37914471, 38112478, 38149824, 38149825, 38181969, 38290725, 38342768, 38342769, 38647607, 38647608, 38647615, 38647616, 38649502, 38687333, 38687334, 38708446, 39029659, 40466126, 40466127, 40466473, 40476395, 40485647, 40485732, 40501047, 40504656, 40504657, 40508315, 40512996, 40512997, 40519832, 40519833;Quantity: 1212Recall no. Z-0249-2027Class II

  28. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155; Material Number: M001195620

    Codes/lots: Material Number: M001195620; UDI-DI: 08714729839613; Batch Numbers: 37775591, 37886793, 37914472, 37914473, 37957744, 38112479, 38149826, 38167704, 38175797, 38444076, 38446234, 38530457, 38745190, 38990885, 39140998, 39140999, 40470358, 40499682, 40499683, 40502254, 40504732, 40504733, 40507436, 40524004, 40539147, 40539467;Quantity: 598Recall no. Z-0250-2027Class II

  29. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number: M001195640

    Codes/lots: Material Number: M001195640; UDI-DI: 08714729839637; Batch Numbers: 37849390, 37914474, 37914475, 37957745, 38022639, 38022640, 38112640, 38181970, 38181971, 38224584, 38259484, 38290726, 38290727, 38290728, 38399245, 38399246, 38399247, 38444840, 38444841, 38444842, 38460462, 38479512, 38484293, 38484294, 38530458, 38530459, 38560742, 38560752, 38708442, 38708443, 38708444, 38708445, 38769962, 38769963, 38769964, 38810598, 38810599, 38810760, 38810761, 38876169, 38916621, 38970725, 38970726, 38970727, 38970728, 38970732, 38970733, 38970734, 39029800, 39074448, 40466474, 40466590, 40466591, 40Quantity: 3145Recall no. Z-0251-2027Class II

  30. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155; Material Number: M001195650

    Codes/lots: Material Number: M001195650; UDI-DI: 08714729839644; Batch Numbers: 37886794, 37957747, 38022670, 38049176, 38149828, 38175798, 38224585, 38259485, 38323409, 38506199, 38531120, 38560457, 38595646, 38595647, 38745191, 38769968, 38769971, 38916516, 38970729, 38990859, 38990882, 39027327, 39141260, 39189845, 40466132, 40466133, 40466134, 40485781, 40493314, 40502331, 40502332, 40502333, 40504594, 40507434, 40507435, 40531377, 40535710, 40535711, 40537146;Quantity: 860Recall no. Z-0252-2027Class II

  31. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130; Material Number: M001195660

    Codes/lots: Material Number: M001195660; UDI-DI: 08714729839651; Batch Numbers: 37914476, 38629575, 38650015, 38687321, 39029882, 39029883, 40466020, 40466021, 40466135, 40507481, 40510684, 40539451;Quantity: 156Recall no. Z-0253-2027Class II

  32. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670

    Codes/lots: Material Number: M001195670; UDI-DI: 08714729839668; Batch Numbers: 37881100, 37889829, 37914477, 37914478, 37914479, 37943144, 37981351, 37981352, 38002448, 38002449, 38002450, 38017051, 38017052, 38022674, 38022676, 38073300, 38073301, 38273216, 38330740, 38350327, 38362202, 38399248, 38399249, 38434624, 38434625, 38439685, 38439687, 38445013, 38560448, 38560451, 38687322, 38810583, 38810585, 38827798, 38827799, 38902297, 38902298, 38916513, 38990275, 38990276, 38990277, 39092688, 39092689, 39143520, 39189848, 40466136, 40466717, 40476440, 40476441, 40492317, 40492357, 40493443, 40507482, 40Quantity: 1442Recall no. Z-0254-2027Class II

  33. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130; Material Number: M001195710

    Codes/lots: Material Number: M001195710; UDI-DI: 08714729839682; Batch Numbers: 38092414, 38149829, 38181972, 38259486, 38324071, 38416363, 38593058, 38595655, 38629567, 38649848, 38745196, 38810589, 38810590, 38937264, 39092268, 40465990, 40466018, 40466019, 40466137;Quantity: 609Recall no. Z-0255-2027Class II

  34. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155; Material Number: M001195720

    Codes/lots: Material Number: M001195720; UDI-DI: 08714729839699; Batch Numbers: 38049560, 38092415, 38112641, 38112642, 38181973, 38210072, 38224586, 38224587, 38239068, 38399299, 38595657, 38595658, 38629568, 38650000, 40493316, 40493317, 40495081, 40504596, 40504689, 40504690, 40512594, 40523965, 40525821;Quantity: 378Recall no. Z-0256-2027Class II

  35. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130; Material Number: M001195740

    Codes/lots: Material Number: M001195740; UDI-DI: 08714729839712; Batch Numbers: 38092416, 38112643, 38149830, 38181974, 38224588, 38224589, 38259488, 38273747, 38273748, 38290697, 38330742, 38399250, 38416365, 38445016, 38484295, 38593059, 38595656, 38649843, 38649864, 38745197, 38810587, 38810592, 38876171, 38876172, 38904806, 38937263, 38990883, 39092270, 39143220, 39189853, 39189855, 40485616, 40485617, 40492473, 40493384, 40497670, 40497857, 40499760, 40499761, 40502300, 40502325, 40507454, 40518477, 40518478, 40525595, 40525718, 40525719, 40536127;Quantity: 1135Recall no. Z-0257-2027Class II

  36. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750

    Codes/lots: Material Number: M001195750; UDI-DI: 08714729839729; Batch Numbers: 38049562, 38112644, 38112645, 38181975, 38259489, 38273638, 38342770, 38346223, 38399380, 38707974, 39074174, 39074176, 39092273, 40470667, 40476303, 40485786, 40485787, 40493318, 40495100, 40507439, 40512986, 40512987, 40523966, 40524003, 40531398, 40531399;Quantity: 432Recall no. Z-0258-2027Class II

  37. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810

    Codes/lots: Material Number: M001195810; UDI-DI: 08714729839743; Batch Numbers: 37914480, 37957748, 38022641, 38149831, 38224590, 38446222, 38649514, 39074449, 39074450, 39074451, 39187259, 39187840, 39187841, 40476396, 40485725, 40493312, 40504693, 40507433, 40510780, 40513102, 40513103;Quantity: 658Recall no. Z-0259-2027Class II

  38. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840

    Codes/lots: Material Number: M001195840; UDI-DI: 08714729839774; Batch Numbers: 37818448, 37818450, 37849391, 37849392, 37849393, 37849394, 37914481, 37914482, 37914483, 37957749, 37957750, 37957751, 37957752, 37981353, 37981354, 37981355, 37981356, 38002451, 38002452, 38002453, 38002454, 38002455, 38002456, 38022642, 38022643, 38022644, 38022645, 38049173, 38065519, 38065520, 38065522, 38065523, 38065524, 38065525, 38065527, 38065528, 38065529, 38065531, 38065532, 38065533, 38106627, 38106628, 38106630, 38149832, 38149833, 38149834, 38149835, 38149836, 38181976, 38181977, 38181978, 38181979, 38181980, 38Quantity: 7945Recall no. Z-0260-2027Class II

  39. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number: M001195850

    Codes/lots: Material Number: M001195850; UDI-DI: 08714729839781; Batch Numbers: 37996606, 38022677, 38022678, 38065534, 38065535, 38112646, 38149837, 38224591, 38259492, 38290688, 38446231, 38769969, 38769970, 38810249, 38875417, 38936818, 38970730, 38970731, 38990886, 39074178, 40466463, 40466605, 40466606, 40470665, 40470666, 40476198, 40484940, 40485711, 40485712, 40485782, 40492387, 40507437, 40512910, 40512911, 40512912, 40512914, 40523982, 40524002, 40525713, 40531378, 40537147;Quantity: 926Recall no. Z-0261-2027Class II

  40. Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130; Material Number: M001195910

    Codes/lots: Material Number: M001195910; UDI-DI: 08714729839828; Batch Numbers:38240235, 38273744, 39092271, 40464692, 40464699, 40531397;Quantity: 86Recall no. Z-0262-2027Class II

  41. Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number: M001195940

    Codes/lots: Material Number: M001195940; UDI-DI: 08714729839842; Batch Numbers:38061297, 38092418, 38149838, 38181982, 38224592, 38240234, 38240236, 38273745, 38649863, 38810593, 39143039, 39189852, 40466138, 40466139, 40466464, 40470781, 40476389, 40478986, 40497669, 40502265, 40507286, 40512989, 40525717;Quantity: 550Recall no. Z-0263-2027Class II

Update history

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