Quick Facts at a Glance
- Recall Date
- May 13, 2026
- Hazard Level
- HIGH
- Brand
- Medtronic Neuromodulation
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medtronic Neuromodulation
- Model numbers
- GTIN 00643169090866, Lot Number VA368G3, Lot Number VA36V7T, GTIN 00643169936584, Lot Number VA3347Y, Lot Number VA33481, Lot Number VA33M8V, Lot Number VA33M92 +4 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 13, 2026
Reported by FDA DEVICE
June 3, 2026
RecallRadar source check
June 10, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic Neuromodulation or your healthcare provider for instructions. Notification method: Letter
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Full Description
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor. Reason: A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.. Classification: Class II. Quantity: 31 units. Distribution: Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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