FDA recall, , Moderate risk
Medtronic 1x4 and 2x4 Pocket Adaptor Kit for Deep Brain Stimulation
The Medtronic Pocket Adaptor Kits are labeled with incorrect Use-By-Dates.
Summary by Recall Canary from the FDA notice
What happened
Medtronic Neuromodulation of Minneapolis, Minnesota, recalled its Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001, and Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002, because a limited number of the kits are labeled with incorrect Use-By-Dates.
The recall began May 13, 2026, and was classified by the FDA on May 28, 2026, with distribution nationwide and in Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Affected if its UDI-DI and lot code are listed under that product.
Incomplete list: 56 of 119 lot codes shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
- UDI-DI
- 00643169090866
- 00643169936584
- 00763000963040
- 00763000968427
- 0231980220
- 0231980221
- 0231980222
- 00763000968434
- 0231493884
- 0231493885
- 0231494066
- 0231928923
- 0231929188
- 0231929189
- 0231929192
- 00763000968441
- 0231367316
- 0231367317
- 0231367319
- 0231367320
- 0231367321
- 0231367322
- 0231514399
- 0231514400
- 0231514401
- 0231514402
- 0231514403
- 0231514404
- 0231514405
- 0231514406
- 0231514407
- 0231514408
- 0231514409
- 0231514410
- 0231514411
- 0231514412
- 0231514413
- 0231929193
- 0231929194
- 0231929195
- 0231929196
- 0231929197
- 0231929198
- 0231929199
- 0231929200
- 0231929201
- 0232153351
- 0232153352
- 0232153353
- 0232153354
- 0232153355
- 0232153360
- 0232212159
- 0232212160
- 0232212161
- 0232224165
- 0232224206
- 0232224207
- 0232224208
- 0232224209
- 0232224211
- 0232224212
- 0232224213
- 0232224214
- 0232224215
- 0232224216
- 0232224217
- 0232224218
- 0232546510
- 0232546511
- 0232554256
- 0232554257
- 0232589003
- 0232589646
- 0232589647
- 0232589648
- 0232589649
- 0232589651
- 0232676531
- 0232676532
- 0232676533
- 0232676534
- 0232676535
- 0232676536
- 0232676537
- 0232676539
- 0232676540
- 0232676541
- 0232725690
- 0232725694
- 0232725695
- 0232725696
- 0232725699
- Lot code
- VA368G3
- VA36V7T
- VA3347Y
- VA33481
- VA33M8V
- VA33M92
- VA33T31
- VA33T33
- VA35B5D
- VA35B5E
- VA35WSP
- VA35WSU
- VA35TTU
- VA35TTV
- VA368FZ
- VA36V8Q
- 0231980220
- 0231980221
- 0231980222
- 0231493884
- 0231493885
- 0231494066
- 0231928923
- 0231929188
- 0231929189
- 0231929192
- 0231367316
- 0231367317
- 0231367319
- 0231367320
- 0231367321
- 0231367322
- 0231514399
- 0231514400
- 0231514401
- 0231514402
- 0231514403
- 0231514404
- 0231514405
- 0231514406
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
- UDI-DI
- 00643169090866
- 00643169936584
- 00763000963040
- 00763000968427
- 0231980220
- 0231980221
- 0231980222
- 00763000968434
- 0231493884
- 0231493885
- 0231494066
- 0231928923
- 0231929188
- 0231929189
- 0231929192
- 00763000968441
- 0231367316
- 0231367317
- Lot code
- VA368G3
- VA36V7T
- VA3347Y
- VA33481
- VA33M8V
- VA33M92
- VA33T31
- VA33T33
- VA35B5D
- VA35B5E
- VA35WSP
- VA35WSU
- VA35TTU
- VA35TTV
- VA368FZ
- VA36V8Q
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
- Company
- Medtronic NeuromodulationMinneapolis, Minnesota
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98913
- Recall numbers
- Z-2240-2026 to Z-2241-2026
All recalls from Medtronic Neuromodulation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
