{"recall":{"id":"fda-device-99906","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Boston Scientific Cork, Ltd. recalls 41 products","firm":"Boston Scientific Cork, Ltd.","date":"2026-09-16","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number: M001195200","code":"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":"126","number":"Z-0223-2027","classification":"Class II"},{"name":"Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number: M001195210","code":"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, 40514122, 40514123, 40514222, 40514223, 40533342, 40533344, 40536165, 40536166;","quantity":"2547","number":"Z-0224-2027","classification":"Class II"},{"name":"Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155; 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Material Number: M001195850","code":"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":"926","number":"Z-0261-2027","classification":"Class II"},{"name":"Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130; Material Number: M001195910","code":"Material Number: M001195910; UDI-DI: 08714729839828; Batch Numbers:38240235, 38273744, 39092271, 40464692, 40464699, 40531397;","quantity":"86","number":"Z-0262-2027","classification":"Class II"},{"name":"Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number: M001195940","code":"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":"550","number":"Z-0263-2027","classification":"Class II"}],"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).","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.","nationwide":true,"states":[],"units":"126; 2547; 459; 689; 8542; 1292; 358; 1912; 381; 42; 3284; 486; 632; 206; 748; 384; 39; 902; 228; 76; 620; 357; 382; 45; 1349; 112; 1212; 598; 3145; 860; 156; 1442; 609; 378; 1135; 432; 658; 7945; 926; 86; 550","remedy":"","whatToDo":"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.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99906","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"209e83b3423ee4f7","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99906","record":[{"status":"Ongoing","city":"Cork","state":"","country":"Ireland","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99906","recalling_firm":"Boston Scientific Cork, Ltd.","address_1":"Boston Scientific Limited, Business And Technology Park, Model Farm Road","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution   US Nationwide and territory of Puerto Rico. 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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.","recall_number":"Z-0226-2027","product_description":"Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105;  Material Number: M001195230","product_quantity":"689","reason_for_recall":"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.","recall_initiation_date":"20260916","center_classification_date":"20261022","report_date":"20261028","code_info":"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;","more_code_info":""},{"status":"Ongoing","city":"Cork","state":"","country":"Ireland","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99906","recalling_firm":"Boston Scientific Cork, Ltd.","address_1":"Boston Scientific Limited, Business And Technology Park, Model Farm Road","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution   US Nationwide and territory of Puerto Rico. 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