FDA Medical Device · Z-2241-2026

Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor

Class II · Ongoing

A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

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Affected lots / codes — check yours against thisGTIN 00643169090866, Lot Number VA368G3; GTIN 00643169090866, Lot Number VA36V7T; GTIN 00643169936584, Lot Number VA3347Y; GTIN 00643169936584, Lot Number VA33481; GTIN 00643169936584, Lot Number VA33M8V; GTIN 00643169936584, Lot Number VA33M92; GTIN 00643169936584, Lot Number VA33T31; GTIN 00643169936584, Lot Number VA33T33; GTIN 00643169936584, Lot Number VA35B5D; GTIN 00643169936584, Lot Number VA35B5E; GTIN 00643169936584, Lot Number VA35WSP; GTIN 00643169936584, Lot Number VA35WSU; GTIN 00763000963040, Lot Number VA35TTU; GTIN 00763000963040, Lot Number VA35TTV; GTIN 00763000963040, Lot Number VA368FZ; GTIN 00763000963040, Lot Number VA368G3; GTIN 00763000963040, Lot Number VA36V7T; GTIN 00763000963040, Lot Number VA36V8Q; GTIN 00763000968427, Lot Number 0231980220; GTIN 00763000968427, Lot Number 0231980221; GTIN 00763000968427, Lot Number 0231980222; GTIN 00763000968434, Lot Number 0231493884; GTIN 00763000968434, Lot Number 0231493885; GTIN 00763000968434, Lot Number 0231494066; GTIN 00763000968434, Lot Number 0231928923; GTIN 00763000968434, Lot Number 0231929188; GTIN 00763000968434, Lot Number 0231929189; GTIN 00763000968434, Lot Number 0231929192; GTIN 00763000968441, Lot Number 0231367316; GTIN 00763000968441, Lot Number 0231367317.
Recalling firm
Medtronic Neuromodulation, Minneapolis, MN
Classification
Class II (temporary or reversible harm possible)
Status
Ongoing
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.
Recall initiated
May 13, 2026
Classified
May 28, 2026
Initiation
Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2241-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →