Medtronic 1x4 pocket adaptor kits carry incorrect use-by dates
Medtronic 1x4 Pocket Adaptor Kits for Deep Brain Stimulation, model 64001, are being recalled because a limited number are labeled with incorrect use-by dates. 275 units 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: FDA Class II recall for a date labeling error with no direction or consequence described in the source, which fits the minor labeling band at Moderate.
Plain-English summary
The Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, model 64001, is being recalled. The action covers 275 units, GTIN 00643169090866, lot numbers VA368G3 and VA36V7T among others listed in the recall notice.
The stated reason is that a limited number of Pocket Adaptor Kits, models 64001 and 64002, are labeled with incorrect use-by dates. The FDA classified the action as Class II. The source does not state the direction of the error or describe any resulting hazard.
Distribution was worldwide, covering the United States nationwide and Austria, France, Germany and other markets. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the GTIN and lot numbers in the recall notice and follow the instructions issued by Medtronic.
The recalled product
- Product
- Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 275
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.
Part of a larger recall action
This product is one of 2 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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