Class II U.S. Food and Drug Administration

Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001 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

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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-2240-2026
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
275 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; GTIN 00763000968441, Lot Number 0231367319; GTIN 00763000968441, Lot Number 0231367320; GTIN 00763000968441, Lot Number 0231367321; GTIN 00763000968441, Lot Number 0231367322; GTIN 00763000968441, Lot Number 0231514399; GTIN 00763000968441, Lot Number 0231514400; GTIN 00763000968441, Lot Number 0231514401; GTIN 00763000968441, Lot Number 0231514402; GTIN 00763000968441, Lot Number 0231514403; GTIN 00763000968441, Lot Number 0231514404; GTIN 00763000968441, Lot Number 0231514405; GTIN 00763000968441, Lot Number 0231514406; GTIN 00763000968441, Lot Number 0231514407; GTIN 00763000968441, Lot Number 0231514408; GTIN 00763000968441, Lot Number 0231514409; GTIN 00763000968441, Lot Number 0231514410; GTIN 00763000968441, Lot Number 0231514411; GTIN 00763000968441, Lot Number 0231514412; GTIN 00763000968441, Lot Number 0231514413; GTIN 00763000968441, Lot Number 0231929193; GTIN 00763000968441, Lot Number 0231929194; GTIN 00763000968441, Lot Number 0231929195; GTIN 00763000968441, Lot Number 0231929196; GTIN 00763000968441, Lot Number 0231929197; GTIN 00763000968441, Lot Number 0231929198; GTIN 00763000968441, Lot Number 0231929199; GTIN 00763000968441, Lot Number 0231929200; GTIN 00763000968441, Lot Number 0231929201; GTIN 00763000968441, Lot Number 0232153351; GTIN 00763000968441, Lot Number 0232153352; GTIN 00763000968441, Lot Number 0232153353; GTIN 00763000968441, Lot Number 0232153354; GTIN 00763000968441, Lot Number 0232153355; GTIN 00763000968441, Lot Number 0232153360; GTIN 00763000968441, Lot Number 0232212159; GTIN 00763000968441, Lot Number 0232212160; GTIN 00763000968441, Lot Number 0232212161; GTIN 00763000968441, Lot Number 0232224165; GTIN 00763000968441, Lot Number 0232224206; GTIN 00763000968441, Lot Number 0232224207; GTIN 00763000968441, Lot Number 0232224208; GTIN 00763000968441, Lot Number 0232224209; GTIN 00763000968441, Lot Number 0232224211; GTIN 00763000968441, Lot Number 0232224212; GTIN 00763000968441, Lot Number 0232224213; GTIN 00763000968441, Lot Number 0232224214; GTIN 00763000968441, Lot Number 0232224215; GTIN 00763000968441, Lot Number 0232224216; GTIN 00763000968441, Lot Number 0232224217; GTIN 00763000968441, Lot Number 0232224218; GTIN 00763000968441, Lot Number 0232546510; GTIN 00763000968441, Lot Number 0232546511; GTIN 00763000968441, Lot Number 0232554256; GTIN 00763000968441, Lot Number 0232554257; GTIN 00763000968441, Lot Number 0232589003; GTIN 00763000968441, Lot Number 0232589646; GTIN 00763000968441, Lot Number 0232589647; GTIN 00763000968441, Lot Number 0232589648; GTIN 00763000968441, Lot Number 0232589649; GTIN 00763000968441, Lot Number 0232589651; GTIN 00763000968441, Lot Number 0232676531; GTIN 00763000968441, Lot Number 0232676532; GTIN …
UPC codes
00643169090866, 00643169936584, 00763000963040, 00763000968427, 00763000968434, 00763000968441

Products covered by this recall

Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; 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.

  • 64001

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 — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  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.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

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 64001. 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?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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