Medtronic Deep Brain Stimulation Adaptor Kits Recalled for Incorrect Use-By-Dates
Medtronic is recalling 275 Pocket Adaptor Kits for Deep Brain Stimulation due to incorrect Use-By-Dates on product labeling. Limited units worldwide are affected.
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: This is a Class II medical device recall for labeling errors (incorrect Use-By-Dates) with no reported illnesses or injuries. The issue involves product documentation errors without confirmed device malfunctions or patient harm.
Plain-English summary
Medtronic Neuromodulation is recalling a limited number of 1x4 Pocket Adaptor Kits, Model 64001, for Deep Brain Stimulation systems used to treat Parkinsonian tremor. The product labeling contains incorrect Use-By-Dates.
A total of 275 units have been distributed worldwide, including throughout the United States and to Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, and the United Kingdom. The incorrect use-by date information on the labeling could result in devices being used beyond their intended service period.
Patients and healthcare providers should verify their device lot numbers against the recall information provided by the FDA. Units identified as part of this recall should be removed from use and not used by patients. For complete lot numbers and product codes, refer to the official FDA recall notice.
The recalled product
- Product
- Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- labeling-error
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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