Medtronic 1x4 Pocket Adaptor Kit for Deep Brain… recallZ-2240-2026 · Medtronic Neuromodulation · initiated May 13, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
FDA root cause category: Under Investigation by firm
What the company is doing
Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 5/13/2026 via UPS 2 day mail. The notice described the issue and requested the following: Actions: " Identify and segregate affected products within your inventory. " Return all unused affected product(s) to Medtronic as described in the Consignee Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected product. " Share this notice with all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. " Complete and return the consignee confirmation form even if you do not have unused inventory. For questions regarding this communication, please contact your Medtronic Representative or Technical Services at 1-800-707-0933.
Recall details
- Recall number
- Z-2240-2026
- Status
- Open, Classified
- Initiated by the company
- May 13, 2026
- Posted by the FDA
- May 28, 2026
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 275 units
- Product code
- MHY
- FDA submissions
- P960009
- Distribution
- Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
Product description
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
Code information (models, lots, serial numbers)
Show the full code information (5k characters)
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 00763000968441, Lot Number 0232676533; GTIN 00763000968441, Lot Number 0232676534; GTIN 00763000968441, Lot Number 0232676535; GTIN 00763000968441, Lot Number 0232676536; GTIN 00763000968441, Lot Number 0232676537; GTIN 00763000968441, Lot Number 0232676539; GTIN 00763000968441, Lot Number 0232676540; GTIN 00763000968441, Lot Number 0232676541; GTIN 00763000968441, Lot Number 0232725690; GTIN 00763000968441, Lot Number 0232725694; GTIN 00763000968441, Lot Number 0232725695; GTIN 00763000968441, Lot Number 0232725696; GTIN 00763000968441, Lot Number 0232725699.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
Other devices under the same FDA submission
88 devices cleared under P960009 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ACTIVA RC 37612Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS2,839 reports
- Activa® RC 37612Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 deaths1,849 reports
- ACTIVA PC 37601Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)15 deaths1,625 reports
- Activa® 37612Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS1,325 reports
- Activa® 37603Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR8 deaths1,093 reports
- Percept™ RC B35300Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian symptoms1 recall3 deaths796 reports
- Activa® 37602Medtronic, Inc. · Deep brain stimulator for obsessive compulsive disorder (OCD)1 recall6 deaths777 reports
- Percept™ PC BrainSense™ B35200Medtronic, Inc. · Deep brain stimulator for obsessive compulsive disorder (OCD)4 recalls1 death547 reports
- Percept™ PC BrainSense™ B35200Medtronic, Inc. · Stimulator, thalamic, epilepsy, implanted1 recall5 deaths543 reports
- Percept™ PC BrainSense™ B35200Medtronic, Inc. · Stimulator, thalamic, epilepsy, implanted1 recall478 reports
- Activa® PC 37601Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS3 deaths521 reports
- Activa® PC 37601Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)1 death502 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98913).
- Z-2241-2026 · Open, ClassifiedMedtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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