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

Medical DevicesSource: FDA (device) · Date: 2026-06-03

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medtronic Neuromodulation
Product
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
Reason / hazard
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
Recall initiated
2026-05-13
Code info
GTIN 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.
Product quantity
31 units
Voluntary mandated
Voluntary: Firm initiated
City
Minneapolis
State
MN
Country
United States
Event id
98913
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