Class II U.S. Food and Drug Administration

Medtronic Neuromodulation InterStim SureScan MRI Leads 978A1 & 978B1: Lead 978A128 recall: Wrong lead or percutaneous extension selected. Use of an incompatible lead

Recall published 5 days ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0266-2027
Published
October 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic Neuromodulation
Product type
Medical devices
Units affected
94,441 (US); 60,488 (OUS)
Distribution
Nationwide
Made in
United States
Lot / code info
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 VA29GYM VA29GYN VA29GYP VA29GYQ VA29J36 VA29J37 VA29J38 VA29K6E VA29K6G VA29K6H VA29K6J VA29K6L VA29LER VA29LET VA29LEU VA29LHU VA29MHS VA29RKQ VA29RKR VA29RL0 VA29RVS VA29SLG VA29U3F VA29U3G VA29VGP VA2A15H VA2A15J VA2A15K VA2A16H VA2A16L VA2A16M VA2A16N VA2A7L1 VA2A7L2 VA2A98D VA2A98E VA2A98F VA2A98G VA2AAUK VA2AAUL VA2AAUN VA2AAUP VA2ADDK VA2AE7E VA2AGD0 VA2AGD1 VA2AGD2 VA2AGD3 VA2AGD4 VA2AGEZ VA2AH78 VA2AHNP VA2AHZZ VA2AJ00 VA2AJ01 VA2AJ03 VA2AJ11 VA2AJ1D VA2AJ1E VA2ALYL VA2ALYM VA2ALYV VA2ALYW VA2ALYX VA2ALYY VA2ALYZ VA2ALZ0 VA2ANFH VA2ANFJ VA2ANFK VA2ANFL VA2ANFP VA2ANFQ VA2AS15 VA2AS16 VA2AS17 VA2AS40 VA2AYAR VA2B6WG VA2B6WH VA2B6WJ VA2B7YF VA2B7YK VA2B7YL VA2B7YM VA2B7YN VA2B7YP VA2B7YQ VA2B9NH VA2B9Y7 VA2B9Y8 VA2B9Y9 VA2B9YA VA2B9YB VA2BA07 VA2BAKM VA2BARD VA2BARM VA2BASK VA2BAST VA2BC27 VA2BFJU VA2BH6Z VA2BH70 VA2BH72 VA2BH73 VA2BH75 VA2BKPW VA2BM6T VA2BN5F VA2BN5L VA2BN5N VA2BN5R VA2BNLL VA2BNP7 VA2BNPK VA2BNPS VA2BQ9Q VA2BT24 VA2BT2Q VA2BT2Y VA2BT30 VA2BT31 VA2BT3W VA2BUTF VA2BUTM VA2BVSV VA2BVTA VA2BVX3 VA2BVX7 VA2BVXD VA2BVXQ VA2BVXX VA2BVY8 VA2BWRU VA2BXTN VA2BXU6 VA2BXUC VA2BXUJ VA2BZTT VA2BZTW VA2BZU1 VA2BZU4 VA2BZVK VA2BZVR VA2BZVU VA2BZVV VA2BZVX VA2C1FP VA2C1GD VA2C1GE VA2C1HV VA2C1HX VA2C1YK VA2C23C VA2C25J VA2C2AA VA2C2BN VA2C2C4 VA2C2CV VA2C2DZ VA2C2XF VA2C3MY VA2CAZ1 VA2CBWD VA2CBWG VA2CBWW VA2CC9M VA2CCAZ VA2CCQT VA2CCW3 VA2CCXM VA2CCY4 VA2CCYT VA2CCYY VA2CCZX VA2CDY5 VA2CE0R VA2CE17 VA2CE1K VA2CEEV VA2CEFA VA2CERU VA2CERY VA2CG7L VA2CG8K VA2CG8R VA2CGSS VA2CLVF VA2CLVL VA2CM1A VA2CM2K VA2CM4K VA2CN4W VA2CN59 VA2CN5Y VA2CN62 VA2CN69 VA2CN6E VA2CQTX VA2CTWB VA2CTWC VA2CTX0 VA2CTX6 VA2CTXA VA2CTXB VA2CU17 VA2CVWY VA2CVX3 VA2CVX7 VA2CVXF VA2CVXU VA2CW4J VA2CW4L VA2CW4N VA2CW4R VA2CWPE VA2CWPP VA2CWQ2 VA2CWW6 VA2CWWE VA2CWWM VA2CWX8 VA2CWXB VA2CWXQ VA2CWXS VA2CWY0 VA2CXPH VA2D0YC VA2D0YU VA2D1PN VA2D1PS VA2D1PY VA2D2L0 VA2D36R VA2D36X VA2D37N VA2D3CG VA2D3DZ VA2D3EQ VA2D3EX VA2D3F5 VA2D3F7 VA2D3FE VA2D3G8 VA2D3GG VA2D3M0 VA2D3M7 VA2D4DE VA2D4DP VA2D4E4 VA2D4E6 VA2D4EF VA2D4XE VA2D4Y4 VA2D4YY VA2D4Z2 VA2D53C VA2D53H VA2D53J VA2D7ES VA2D967 VA2D9VR VA2DA0E VA2DA0K VA2DBA6 VA2DBZX VA2DCQZ VA2DCR1 VA2DCR2 VA2DCR3 VA2DCXD VA2DCXJ VA2DCXP VA2DCXX VA2DDKH VA2DDRG VA2DDS9 VA2DDV0 VA2DDVU VA2DDZG VA2DDZS VA2DE04 VA2DE0J VA2DE2W VA2DE71 VA2DE8M VA2DE99 VA2DEZQ VA2DEZR VA2DF0F VA2DF1L VA2DF1V VA2DF1Z VA2DF20 VA2DF2B VA2DF2L VA2DF2U VA2DFD9 VA2DFDV VA2DFE5 VA2DFE7 VA2DFGA VA2DG6P VA2DG74 VA2DG7R VA2DG7X VA2DG83 VA2DG87 VA2DHN7 VA2DHNG VA2DHP9 VA2DHRN VA2DHSY VA2DHT1 VA2DHT7 VA2DHT8 VA2DHTK VA2DJ8R VA2DJ8S VA2DRUM VA2DRUN VA2DS14 VA2DS20 VA2DS26 VA2DSS0 VA2DSS1 VA2DSS2 VA2DSS6 VA2DWDL VA2DWDY VA2DX9R VA2DXFA VA2DXFC VA2DXFF VA2DXFW VA2DXGD VA2DXGN VA2DXH3 VA2DXH9 VA2DXHA VA2DXHK VA2DXHL VA2DYQ1 VA2DYR1 VA2DYSS VA2DYSZ VA2DYTD VA2DYU4 VA2E…
UPC codes
00763000203603, 00763000203610, 00763000203634, 00763000586966, 00763000596798, 00763000596804, 00763000913069, 00763000203641, 00763000203658, 00763000596835, 00763000596842, 00763000913083, 00763000203689, 00763000203696, 00763000596873, 00763000596880, 00763000203726, 00763000203733, 00763000203757, 00763000586959

Products covered by this recall

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

Check your product

The notice names 46 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00763000203603
  • 00763000203610
  • 00763000203634
  • 00763000586966
  • 00763000596798
  • 00763000596804
  • 00763000913069
  • 00763000203641
  • 00763000203658
  • 00763000596835
  • 00763000596842
  • 00763000913083
  • 00763000203689
  • 00763000203696
  • 00763000596873
  • 00763000596880
  • 00763000203726
  • 00763000203733
  • 00763000203757
  • 00763000586959

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • VA2WZWH UDI-DI 00763000913069
  • VA2YCTJ UDI-DI 00763000913083
  • VA2X2C3 UDI-DI 00763000596880
  • VA2XJR2
  • VA2X18J UDI-DI 00763000203733
  • VA37LCX

Package size

Match the net weight or the piece count on the front of the pack.

  • 282 KG
  • 2868 L
  • 7 L
  • 6 L
  • 16 L
  • 5 L
  • 4 L
  • 1 L
  • 2 L
  • 52 L
  • 2 PK
  • 53 L
  • 8 L
  • 08 L
  • 267 PK
  • 2975 L
  • 3 CT
  • 8 CT
  • 3 L
  • 0 L

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medtronic Neuromodulation — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Medtronic Neuromodulation — 7000 Central Ave Ne, Minneapolis, MN, 55432-3568

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medtronic Neuromodulation medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00763000203603, 00763000203610, 00763000203634; lot code VA2WZWH UDI-DI 00763000913069, VA2YCTJ UDI-DI 00763000913083, VA2X2C3 UDI-DI 00763000596880. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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