FDA
Food and Drug Administration · Recall Z-2240-2026 · May 13, 2026Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
Medtronic Neuromodulation
The hazard
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model GTIN 00643169090866Model Lot Number VA368G3Model Lot Number VA36V7TModel GTIN 00643169936584Model Lot Number VA3347YModel Lot Number VA33481Model Lot Number VA33M8VModel Lot Number VA33M92Model Lot Number VA33T31Model Lot Number VA33T33Model Lot Number VA35B5DModel Lot Number VA35B5EModel Lot Number VA35WSPModel Lot Number VA35WSUModel GTIN 00763000963040UPC 00643169090866UPC 00643169936584UPC 00763000963040UPC 00763000968427UPC 00763000968434Would you have heard about this one?
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