Medtronic Deep Brain Stimulation Pocket Adaptor Kits recalled for incorrect expiration dates
Medtronic is recalling Pocket Adaptor Kits for deep brain stimulation devices due to incorrect Use-By-Dates on product labels. The recall affects 31 units distributed worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with only a labeling defect (incorrect Use-By-Dates) and no reported illnesses or injuries. Per the rubric, minor labeling errors with no reported harm are classified as Moderate.
Plain-English summary
Medtronic Neuromodulation is recalling a limited number of Pocket Adaptor Kits, Models 64001 and 64002, due to incorrect Use-By-Dates on the product labels. These kits are designed for use with deep brain stimulation devices that treat parkinsonian tremor.
The recall affects 31 units distributed worldwide, including the United States and the countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, and the United Kingdom. The affected lot numbers are detailed in the FDA recall notice Z-2241-2026.
Individuals who believe they may have received one of the affected kits should consult their healthcare provider or contact Medtronic Neuromodulation directly for additional information regarding their specific device and replacement options.
The recalled product
- Product
- Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- mis-labeling
- incorrect-expiration-date
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00643169090866
- Lot Number VA368G3
- Lot Number VA36V7T
- GTIN 00643169936584
- Lot Number VA3347Y
- Lot Number VA33481
- Lot Number VA33M8V
- Lot Number VA33M92
- Lot Number VA33T31
- Lot Number VA33T33
- Lot Number VA35B5D
- Lot Number VA35B5E
- Lot Number VA35WSP
- Lot Number VA35WSU
- GTIN 00763000963040
- Lot Number VA35TTU
- Lot Number VA35TTV
- Lot Number VA368FZ
- Lot Number VA36V8Q
- GTIN 00763000968427
Distribution
Distributed nationwide across the United States.
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