Class II U.S. Food and Drug Administration

Medtronic Neuromodulation InterStim Percutaneous Extensions EXT 3560022 Istm II Perc 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-0267-2027
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
56,331 (US); 40,211 (OUS)
Distribution
Nationwide
Made in
United States
Lot / code info
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 VA27VWY VA27Y21 VA27Y22 VA27YF8 VA27YFG VA280D1 VA280E6 VA280LQ VA2848G VA28499 VA284MR VA284PJ VA284S3 VA286PS VA286PT VA2872W VA28AQH VA28BDU VA28BEW VA28BR6 VA28BR7 VA28DZR VA28E02 VA28EC2 VA28EC3 VA28GE3 VA28HC2 VA28HM9 VA28HSG VA28J1R VA28J1S VA28K8K VA28MHH VA28MHS VA28MYN VA28N0Y VA28N15 VA28N1R VA28T7D VA28T7F VA28TSM VA28TSP VA28UE7 VA28UHR VA28UHY VA28Z99 VA28ZJ5 VA28ZMP VA2976F VA297CK VA297CR VA297PV VA2990L VA29939 VA299J7 VA299J8 VA29EQE VA29EQF VA29EQG VA29EQJ VA29FSC VA29FSD VA29FSS VA29G5U VA29G94 VA29GKR VA29HCQ VA29HCU VA29HM5 VA29HM6 VA29N97 VA29QAK VA29QAL VA29QBK VA29QBL VA29QCE VA29QUW VA29QUZ VA29QVN VA29S6N VA29S6Q VA29SAV VA29SDN VA29SEY VA29SEZ VA29SF4 VA29SF5 VA29SYJ VA29Y62 VA29Y63 VA29YGH VA29YGJ VA29YKY VA29YW5 VA29Z8P VA29Z8Q VA29ZEG VA29ZN3 VA29ZSA VA29ZU3 VA29ZU4 VA29ZUG VA2A2Z3 VA2A5JQ VA2A5MK VA2A6GU VA2A6GY VA2A6L5 VA2A73R VA2A73U VA2A7EC VA2A7EF VA2A7HW VA2AEKR VA2AEM9 VA2AEWP VA2ALQ9 VA2ALUD VA2ALV0 VA2ALVA VA2ALW5 VA2APNN VA2APQA VA2APSH VA2APSU VA2ARAX VA2ARCA VA2ARCT VA2AYRR VA2AYRU VA2AYZ3 VA2AZ0W VA2AZ7J VA2AZ7R VA2B6PX VA2B8WD VA2B8WE VA2B8XZ VA2B8ZN VA2BBDN VA2BBDQ VA2BBT6 VA2BBU0 VA2BBWC VA2BBZM VA2BD21 VA2BDCD VA2BDCE VA2BHB0 VA2BHB9 VA2BHCD VA2BHCF VA2BHDU VA2BHDX VA2BHJN VA2BHPH VA2BHPK VA2BHPR VA2BUNB VA2BUNP VA2BUSW VA2BUVT VA2BXXB VA2BY1R VA2BY2N VA2BY4M VA2C4A9 VA2C4JZ VA2C582 VA2C585 VA2C7JX VA2C7LT VA2C7SB VA2CCJ0 VA2CCJ1 VA2CCJK VA2CCJL VA2CCJM VA2CCJN VA2CCJP VA2CCJR VA2CH8Y VA2CHC0 VA2CHET VA2CM6R VA2CM9W VA2CMA3 VA2CMAG VA2CMAL VA2CN36 VA2CPWP VA2CQ0U VA2CQ0Z VA2CQ1G VA2CQ23 VA2CQ2A VA2CSVR VA2CSW9 VA2CSWG VA2CSX2 VA2CT5M VA2CUN8 VA2CVB8 VA2CW13 VA2CZSU VA2CZSV VA2CZSY VA2CZT4 VA2D4PR VA2D4Q5 VA2D4QJ VA2D4QM VA2D4Z4 VA2D4ZU VA2D657 VA2D658 VA2D659 VA2D65A VA2D65B VA2D8B5 VA2DDCK VA2DDCU VA2DDD8 VA2DDDG VA2DDDT VA2DP4Z VA2DPAJ VA2DPCV VA2DPF5 VA2DPNR VA2DVAY VA2DVB5 VA2DVBA VA2DVBF VA2DVDA VA2DVP5 VA2DVPQ VA2E1PW VA2E1PY VA2E1Q1 VA2E1QE VA2E2EK VA2E491 VA2E494 VA2E4A5 VA2E4AC VA2ECQY VA2ECRM VA2ECS4 VA2ECTK VA2ECTM VA2ECTV VA2EGXE VA2EGXJ VA2EGXK VA2EGZ4 VA2EHT8 VA2EMDT VA2EME1 VA2EME9 VA2EMEP VA2EMF5 VA2EMFB VA2EMM1 VA2EMN8 VA2ENF9 VA2ENH4 VA2ENH7 VA2ENJG VA2ENJQ VA2ENJT VA2ENJV VA2ENKX VA2ENW3 VA2EP8C VA2ESRT VA2ESSH VA2ESSW VA2ESTM VA2ESTV VA2ESU0 VA2ESUA VA2ESUK VA2EYMM VA2EYNF VA2EYQQ VA2EYRB VA2F0TM VA2F0U6 VA2F0UV VA2F1B5 VA2F1G2 VA2F1G6 VA2F1GQ VA2F1HH VA2F1XE VA2F1XY VA2F1ZF VA2F202 VA2F21Q VA2F222 VA2F259 VA2F25E VA2F25V VA2F38C VA2F38K VA2F38T VA2F3DE VA2F3ET VA2F3FG VA2F3FX VA2F3G6 VA2F3K6 VA2F4BJ VA2F4E5 VA2F4KD VA2F4M7 VA2F4MY VA2FBYT VA2FBYW VA2FBZJ VA2FBZZ VA2FC00 VA2FC0H VA2FC0T VA2FPRU VA2FWNY VA2FWP1 VA2FWPK VA2FWQJ VA2FZRU VA2FZRY VA2FZRZ VA2FZS1 VA2FZS8 VA2FZSB VA2G05M VA2G05U VA2G06S VA2G06W VA2G06Z VA2G074 VA2G07T VA2G4WX VA2G4X0 VA2G4X5 VA2G4XS VA2G4XV VA2G6MT VA2G6NL VA2G6NZ VA2G6R9 VA2G6RE VA2G79V VA2G7A4 VA2G8J5 VA2G8J7 VA2G8J8 VA2G8S6 VA2G8UC VA2G8UH VA2G8WC VA2G8WP VA2G8WV VA2G8X1 VA2G8X9 VA2G8XG VA2G8YN VA2G8Z6 VA2GDZE VA2GDZF VA2GDZH VA2GDZJ VA2GDZK VA2GDZM VA2GEA9 VA2GEAV VA2GEBH VA2GEDS VA2GEEP VA2GEF3 VA2GH1M VA2GH1W VA2GH25 VA2GH2F VA2GH3Q VA2GH9H VA2GKGQ VA2GKGW VA2GKH1 VA2GKH6 VA2GL2M VA2GL3F VA2GL3N VA2GL6Z VA2GT1C VA2GT1J VA2HF33 VA2HF3H VA2HF3Y VA2HJJU VA2HJJX VA2HJK5 VA2HJX0 VA2HJX4 VA2HJXN VA2HK92 VA2HK98 VA2HK9B VA2HK9C VA2HKK0 VA2HKKE VA2HLVK VA2HLVQ VA2HLW7 VA2HLW9 VA2HLWC VA2HLWD VA2HLWE VA2HMQR VA2HMR1 VA2HMRS VA2HMS7 VA2HMSN VA2HMSQ VA2H…
UPC codes
00763000203894, 00763000587062, 00763000203887, 00763000587000

Products covered by this recall

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

Check your product

The notice names 20 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.

  • 00763000203894
  • 00763000587062
  • 00763000203887
  • 00763000587000

Package size

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

  • 2728 L
  • 2990 L
  • 8 L
  • 6 L
  • 2 ML
  • 51 L
  • 52 L
  • 9 L
  • 1 L
  • 4 L
  • 5 L
  • 366 ML
  • 2 L
  • 49 L
  • 34 L
  • 72 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. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

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 00763000203894, 00763000587062, 00763000203887. 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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