Reported Oct 28, 2026 · Ongoing · Updated Nov 2, 2026
InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- InterStim
- SureScan MRI Leads 978A1 & 978B1LEAD 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
- Lot codes and dates
- 978A128 UDI-DI 00763000203603 LotsUDI-DI 00763000203610 Lots
791 of 791 codes
VA27EGGVA27EGJVA27EGKVA27FKVVA27FKWVA27FKXVA27GABVA27GACVA27GADVA27GAEVA27GAFVA27GAGVA27GVYVA27GXCVA27GXDVA27GXFVA27HLSVA27HLTVA27HLUVA27HLVVA27K2TVA27NK1VA27NLYVA27QTZVA27QUAVA27QUFVA27QUPVA27QURVA27WZNVA27X01VA27YM3VA27YM4VA27YMCVA27YMDVA27YMFVA27YMJVA282HHVA282J1VA282J8VA282JAVA282JYVA282K0VA282KAVA282KGVA284XZVA2868LVA2868MVA2868PVA2868QVA286JCVA286K5VA286MAVA287A7VA287AAVA287DCVA287DHVA287TDVA287X3VA2883CVA2883E
UDI-DI 00763000203634 Lots VA2MVL3 VA2MVL8 VA2R0L7 UDI-DI 00763000586966 Lots182 of 182 codes
VA26G2NVA26G2PVA26LNTVA26LR2VA26LVUVA26LWGVA26LX2VA26LYRVA26XNRVA27RSYVA27RSZVA27RT0VA27RU9VA27SEQVA27SFCVA27SFLVA27SFMVA27SFNVA27SFVVA28B35VA28V1ZVA28V20VA28W7WVA28W7YVA28WA4VA28WLEVA28WLSVA28WMKVA2BUTPVA2BVYJVA2CBWZVA2CBXHVA2CC03VA2CM4MVA2D4EDVA2D6T1VA2DCQUVA2DDYJVA2DE9BVA2DR6AVA2E8CVVA2EEJHVA2EEJKVA2EEJMVA2ER0BVA2ER0PVA2ER2FVA2EXUCVA2EXULVA2EXUNVA2EXUPVA2EXURVA2EXUSVA2EZ25VA2FUE4VA2FUE9VA2FUEUVA2FUG7VA2G0D9VA2G0N7
UDI-DI 00763000596798 LotsVA2JNYGVA2JNYKVA2N0BBVA2N3V2VA2QV41VA2R08PVA2R0KAVA2RAHNVA2XFE8VA2XFFQVA2XWY9VA302S0VA31CUFVA31CUNVA31MBJVA32XZYVA35M5S
UDI-DI 00763000596804 Lots VA2WZWH UDI-DI 00763000913069 Lots87 of 87 codes
VA2X0U5VA2X0U8VA2XB9NVA2XFE8VA2XFE9VA2XFF7VA2XFFQVA2XFJ0VA2XWY3VA2XWY9VA2XWYCVA2YD2DVA2YD2HVA2YD2PVA2YD2PV20VA2YD2XVA2YLWKVA2Z1W6VA2Z1WPVA2Z1WUVA2Z1WWVA2Z1XTVA2ZAW2VA2ZAW4VA2ZK1UVA2ZK1YVA2ZK21VA2ZK2GVA2ZK2SVA2ZNNJVA2ZNNUVA2ZNNWVA2ZNP4VA2ZNPLVA2ZNPQVA2ZNSVVA2ZZFPVA2ZZFQVA2ZZFTVA2ZZFVVA302RPVA302RVVA302S0VA302SLVA302VHVA30KREVA30KRLVA30KSVVA30KSXVA313UZVA313V0VA313V1VA31CUBVA31CUFVA31CUNVA31MBJVA31MBKVA31MBMVA31QC7VA31QC8
VA3AQVG; 978A133 UDI-DI 00763000203641 LotsVA37B0JVA37B0MVA37B0SVA37CMLVA37CMNVA37CN6VA37CN8VA38HPHVA392DEVA392DQVA392DRVA392DSVA392DUVA392JVVA39JNMVA39KCTVA3A3JJVA3A3JMVA3A5S1VA3A5S5VA3ACD2VA3AQVD
UDI-DI 00763000203658 Lots83 of 83 codes
VA27NHTVA27QXBVA27X11VA27YMGVA27YMHVA27YMMVA28095VA282KKVA28B60VA28H5VVA28H6HVA28HA1VA28QN0VA28UBNVA28V9FVA28VGEVA28VGFVA28VNGVA28VNHVA28XDKVA290SEVA29FV5VA29LEVVA2AS4MVA2AS4NVA2AS4PVA2ATGJVA2ATGKVA2ATGLVA2AUGDVA2AUGEVA2AY8RVA2AY8SVA2AY8UVA2AY8YVA2AY8ZVA2BCTNVA2BHV2VA2BHV3VA2C256VA2C2XCVA2C2XDVA2C3Q7VA2C8KUVA2CAYYVA2CG00VA2CG94VA2CGALVA2CN6UVA2CN73VA2CN76VA2D3GNVA2E04MVA2E04SVA2E05TVA2E061VA2E068VA2E06KVA2E0B7VA2E0BG
UDI-DI 00763000596835 LotsVA26LYWVA27GVQVA27NK5VA27SFUVA2BCTXVA2BMD6VA2BXGCVA2EFRLVA2F82YVA2HLQ2VA2JR1RVA2KC29VA2LDHPVA2LMT7VA2QSJUVA2QU89VA2QV91VA2T7DX
UDI-DI 00763000596842 Lots VA2YCTJ UDI-DI 00763000913083 Lots VA3710S VA38HUS VA391US VA391UX VA39KCY VA3A3LX; 978A141 UDI-DI 00763000203689 LotsVA2XB95VA2XB9WVA2XXB6VA2Z3UKVA2ZBKLVA2ZNSWVA303PWVA30KQHVA32HKLVA33NT8VA34K7G
UDI-DI 00763000203696 LotsVA27GW0VA287B0VA2884FVA2884GVA28AXLVA29NDNVA2AE7FVA2BCTWVA2BMDQVA2D4XSVA2DBZSVA2DBZTVA2E1NBVA2EFR4VA2GDZCVA2J707VA2JFZZVA2L0LHVA2UL3Z
UDI-DI 00763000596873 Lots VA2X2C3 UDI-DI 00763000596880 Lots VA2XJR2; 978B128 UDI-DI 00763000203726 Lot VA2X18J UDI-DI 00763000203733 LotsVA26LYVVA27YMNVA29VGQVA2CX5YVA2DN3NVA2DSSAVA2E8UAVA2E8VRVA2QSM8VA2QU1D
UDI-DI 00763000203757 Lots1,375 of 1,375 codes
VA24T4LVA24T4VVA24T5DVA24T5EVA24T6EVA24T6FVA24TD0VA24TM7VA24TM8VA24W3EVA24XW3VA24XW5VA24XWHVA24XZ6VA24YG4VA24YH7VA24YHNVA250WZVA257ZEVA25VKLVA25VKMVA25VKNVA25VKPVA260T5VA2613TVA2613XVA261AAVA261C8VA261CPVA2678VVA2678XVA267KUVA267M1VA267NFVA267PKVA267VWVA268W0VA268W2VA269PGVA269QWVA26A1BVA26A1CVA26A2WVA26B02VA26B08VA26MGDVA26MGNVA26MGUVA26MJKVA26MRBVA26MS3VA26MS4VA26MYNVA26XLYVA26XM0VA26XNNVA27M2DVA27M44VA27M5TVA27M5U
UDI-DI 00763000586959 LotsVA2JH4VVA2JH55VA2JH5AVA2JH5FVA2JV43VA2JV63VA2JV6FVA2JV6XVA2N48SVA2N49EVA2NJM8VA2NJQ9VA2NJQEVA2NJQGVA2NK2UVA2NK33VA2NK4GVA2NK7XVA2NL8LVA2NL8TVA2NL92VA2NL9PVA2NL9SVA2NLA0VA2NRW3VA2NRWRVA2NTSLVA2NU78VA2P5CMVA2P5DTVA2P5DYVA2P5RUVA2PJQLVA2PJR8VA2Q9V3VA2Q9VGVA2RE1FVA2RZC1VA2RZC3VA2RZC7VA2S489VA2SDARVA2SDATVA2ST71VA2ST8GVA2ST90VA2ST93VA2ST96VA2ST9CVA2ST9HVA2SV2DVA2SV2PVA2SV2TVA2SV2ZVA2T24NVA2T5MNVA2T5PBVA2T5PTVA2V5W1VA2V5W2
UDI-DI 00763000596910 Lots81 of 81 codes
VA2WCALVA2WCJXVA2WZ0BVA2WZ0DVA2XBRNVA2XBTNVA2XKWAVA2XLS3VA2XLSGVA2Y783VA2Y78FVA2YHRSVA2YKX8VA2YQ7HVA2Z0UVVA2Z0V0VA2Z4AEVA2Z4AWVA2ZADJVA2ZAFAVA2ZBW2VA2ZJ2XVA2ZXUHVA3124FV08VA313VTVA314SQVA31BS7VA31LA0VA31LGAVA31LH5VA31MG3VA31VE1VA320WSVA32AL6VA32AQ8VA32DCHVA32FW5VA32MK1V19VA32RH4VA335DFVA33HT8VA33NQUVA33ULHVA3408QVA340V7VA34306VA34BWLVA34BXGVA34EMEVA34G56VA34PJZVA34WJAVA34WJTVA34XNWVA34YXXVA354N6VA35FPVVA35H1NVA35MGKVA35NPV
419 of 419 codes
VA2S40XVA2WBEQVA2WBF3VA2WBF4VA2WBF5VA2WBF6VA2WBYUVA2WBZCVA2WBZJVA2WBZNVA2WC01VA2WC05VA2WC06VA2WC07VA2WC0LVA2WC0MVA2WC10VA2WC23VA2WC2KVA2WC2MVA2WC2YVA2WCAKVA2WCALVA2WCJXVA2WCMLVA2WCMMVA2WCMQVA2WCMUVA2WCNAVA2WCPRVA2WCPWVA2WCQ1VA2WCQ7VA2WCQAVA2WCRPVA2WCRTVA2WCS0VA2WCSEVA2WCT4VA2WCT5VA2WCTLVA2WCTMVA2WCTSVA2WCTYVA2WCUNVA2WCUQVA2WCURVA2WCUVVA2WD3FVA2WD3HVA2WD3JVA2WD3SVA2WD42VA2WDFJVA2WDGSVA2WDGYVA2WDKPVA2WDKQVA2WEY4VA2WEYF
- 978A128 UDI-DI 00763000203603 Lots
- Amount recalled
- 94,441 (US); 60,488 (OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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