Medtronic Neuromodulation: Medtronic 2x4 Pocket Adaptor Kit For Deep Brain Stimulation, Model 64002; Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic is recalling certain 2x4 Pocket Adaptor Kits (Models 64001 and 64002) used with deep brain stimulation devices for Parkinson's tremor because some units have incorrect expiration dates printed on the packaging. The recall affects devices distributed worldwide, including across all U.S. states and several European countries, as well as Japan. This is a Class II recall, meaning there is a potential health risk but the situation is not life-threatening.
- Recalling firm
- Medtronic Neuromodulation
- Product
- Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
- Reason
- A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-13
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/601b8cec-95f8-4df7-a4ee-6942ce15b00c