FDA-Device2026-06-03Class IIMISBRANDING
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation recalled for incorrect Use-By-Dates
What this means
A limited number of Medtronic 2x4 Pocket Adaptor Kits (Models 64001 and 64002) were labeled with incorrect Use-By-Dates. The affected kits are used with deep brain stimulation systems to treat parkinsonian tremor. No injuries have been reported.
- Check if your Pocket Adaptor Kit matches one of the affected lot numbers listed in the recall notice
- Contact Medtronic or your healthcare provider to verify whether your kit is affected and obtain a replacement with correct labeling
- Do not use a kit past its labeled Use-By-Date
The agency's original wording
Hazard
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
Affected count
31 units
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2241-2026Also reported as
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