Medtronic Neuromodulation recalls InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED
- Recalling company
- Medtronic Neuromodulation
- Product
- 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
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 8, 2026
- Reported
- Oct 28, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 94,441 (US); 60,488 (OUS)
- Lot / codes
- 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 VA28EUK VA28EVN VA28GUJ VA28H21 VA28H22 VA28H9T VA28H9Z VA28L7U VA28L7V VA28L7W VA28LBA VA28LBD VA28LBF VA28PRE VA28PRG VA28PRH VA28PS8 VA28PUE VA28PVK VA28QHU VA28QHV VA28QHW VA28QNK VA28QPT VA28QPU VA28U5G VA28U5J VA28U5K VA28V6V VA28V71 VA28V77 VA28V79 VA28V7A VA28V7L VA28XDH VA28XDJ VA290PU VA290PV VA290PY VA290PZ VA290Q0 VA290S5 VA297UZ VA297VE VA297VU VA298JA VA298JF VA2990B VA299MT VA29ASB VA29BW5 VA29BX3 VA29BX5 VA29BX6 VA29D8Z VA29D93 VA29D97 VA29D98 VA29D99 VA29ED5 VA29ED6 VA29ED7 VA29ED8 VA29ED9 VA29EDB VA29EHD VA29EHE VA29EN5 VA29FTM VA29FTN VA29FTQ VA29FTS VA29FTT VA29FTU VA29FV3 VA29GYL
- Company location
- Minneapolis, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0266-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0266-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.