Class II U.S. Food and Drug Administration

Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002 recall: A limited number of Pocket Adaptor Kits, Model 64001 and 64002

Recall published 5 months ago

A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

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-2241-2026
Published
June 3, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic Neuromodulation
Product type
Medical devices
Units affected
31 units
Distribution
Nationwide
Made in
United States
Lot / code info
GTIN 00643169090866, Lot Number VA368G3; GTIN 00643169090866, Lot Number VA36V7T; GTIN 00643169936584, Lot Number VA3347Y; GTIN 00643169936584, Lot Number VA33481; GTIN 00643169936584, Lot Number VA33M8V; GTIN 00643169936584, Lot Number VA33M92; GTIN 00643169936584, Lot Number VA33T31; GTIN 00643169936584, Lot Number VA33T33; GTIN 00643169936584, Lot Number VA35B5D; GTIN 00643169936584, Lot Number VA35B5E; GTIN 00643169936584, Lot Number VA35WSP; GTIN 00643169936584, Lot Number VA35WSU; GTIN 00763000963040, Lot Number VA35TTU; GTIN 00763000963040, Lot Number VA35TTV; GTIN 00763000963040, Lot Number VA368FZ; GTIN 00763000963040, Lot Number VA368G3; GTIN 00763000963040, Lot Number VA36V7T; GTIN 00763000963040, Lot Number VA36V8Q; GTIN 00763000968427, Lot Number 0231980220; GTIN 00763000968427, Lot Number 0231980221; GTIN 00763000968427, Lot Number 0231980222; GTIN 00763000968434, Lot Number 0231493884; GTIN 00763000968434, Lot Number 0231493885; GTIN 00763000968434, Lot Number 0231494066; GTIN 00763000968434, Lot Number 0231928923; GTIN 00763000968434, Lot Number 0231929188; GTIN 00763000968434, Lot Number 0231929189; GTIN 00763000968434, Lot Number 0231929192; GTIN 00763000968441, Lot Number 0231367316; GTIN 00763000968441, Lot Number 0231367317.
UPC codes
00643169090866, 00643169936584, 00763000963040, 00763000968427, 00763000968434, 00763000968441

Products covered by this recall

Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor

Check your product

The notice names 27 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.

  • 00643169090866
  • 00643169936584
  • 00763000963040
  • 00763000968427
  • 00763000968434
  • 00763000968441

Lot or batch code

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

  • VA368G3
  • VA36V7T
  • VA3347Y
  • VA33481
  • VA33M8V
  • VA33M92
  • VA33T31
  • VA33T33
  • VA35B5D
  • VA35B5E
  • VA35WSP
  • VA35WSU
  • VA35TTU
  • VA35TTV
  • VA368FZ
  • VA36V8Q
  • 0231980220
  • 0231980221
  • 0231980222
  • 0231493884

Model or item number

On the rating label, the box or the instruction sheet.

  • 64002

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 — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

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?

A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00643169090866, 00643169936584, 00763000963040; lot code VA368G3, VA36V7T, VA3347Y; model number 64002. 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?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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