OVERLOOKED

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Class IIOngoing

Medtronic Neuromodulation recalls 2 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
Medtronic Neuromodulation
Reason
Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.
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 Brazil, Colombia, Chile, Canada, Japan, New Zealand, Australia, United Kingdom, Switzerland, Sweden, Spain, Portugal, Italy, Israel, Germany, France, Finland, Canary Islands, Belgium, Austria, Norway, Northern Ireland, Netherlands, Iceland, Denmark, South Africa, Turkey, Slovakia, Saudi Arabia, Poland, Hungary, United Arab Emirates (UAE), Kuwait, Greece.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99949…

Products (2)

  1. InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A133 LEAD 978A141 ISTM MICRO 41CM SSMRI TINED 978A141 LEAD 978B128 ISTM II 28CM SSMRI TINED 978B128 LEAD 978B133 ISTM II 33CM SSMRI TINED 978B133 LEAD 978B141 ISTM II 41CM SSMRI TINED 978B141

    Codes/lots: 978A128 UDI-DI 00763000203603 Lots VA27EGG VA27EGJ VA27EGK VA27FKV VA27FKW VA27FKX VA27GAB VA27GAC VA27GAD VA27GAE VA27GAF VA27GAG VA27GVY VA27GXC VA27GXD VA27GXF VA27HLS VA27HLT VA27HLU VA27HLV VA27K2T VA27NK1 VA27NLY VA27QTZ VA27QUA VA27QUF VA27QUP VA27QUR VA27WZN VA27X01 VA27YM3 VA27YM4 VA27YMC VA27YMD VA27YMF VA27YMJ VA282HH VA282J1 VA282J8 VA282JA VA282JY VA282K0 VA282KA VA282KG VA284XZ VA2868L VA2868M VA2868P VA2868Q VA286JC VA286K5 VA286MA VA287A7 VA287AA VA287DC VA287DH VA287TD VA287X3 VA2883C VA2883E VA28845 VA2884S VA28AXJ VA28AXK VA28B2T VA28B3Q VA28B5Z VA28EQ9 VA28ETU VA28EUA VA28EQuantity: 94,441 (US); 60,488 (OUS)Recall no. Z-0266-2027Class II

  2. InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030

    Codes/lots: 3560022 UDI-DI 00763000203894 Lots VA24HE7 VA24R5J VA24TXT VA24UYB VA24WJE VA24WJF VA250XH VA25144 VA2515A VA25TEF VA25TEH VA25TEJ VA25TEL VA26A7F VA26AJA VA26AJB VA26AKS VA26AKT VA26AKU VA26AKV VA26C4T VA26CB1 VA26CB2 VA26EHL VA26EHN VA26EHP VA2725R VA2725S VA2726H VA2726J VA2728H VA2728K VA2728L VA275QE VA2760F VA277W0 VA277W1 VA27C85 VA27C86 VA27CCG VA27CEE VA27D4B VA27D62 VA27D63 VA27KEH VA27KGX VA27KHG VA27KHH VA27KHJ VA27KHK VA27KHL VA27NS0 VA27NSC VA27NSG VA27NSH VA27NSJ VA27NSL VA27ST1 VA27ST2 VA27UGK VA27UGL VA27UXN VA27UXP VA27VDZ VA27VED VA27VEE VA27VEF VA27VJF VA27VJG VA27VJJ VA27VQuantity: 56,331 (US); 40,211 (OUS)Recall no. Z-0267-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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