This is part of a larger recall. The most authoritative record is FDA-Device / Z-2241-2026.
FDA-Device2026-06-03Class IIMISBRANDING
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation recalled for incorrect Use-By-Dates
What this means
A limited number of Medtronic 1x4 Pocket Adaptor Kits (Models 64001 and 64002) used in deep brain stimulation devices are labeled with incorrect Use-By-Dates. The mislabeled kits may no longer be safe or effective for their intended use.
- Check your Pocket Adaptor Kit label for the lot number against the affected list.
- Contact Medtronic or your healthcare provider immediately if you have an affected kit.
- Do not use a Pocket Adaptor Kit with an incorrect or unclear 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
275 units
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2240-2026Want us to check the next one for you?
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