Medtronic Neuromodulation: Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic is recalling certain Pocket Adaptor Kits (Model 64001 and 64002) used with deep brain stimulation devices for Parkinson's tremor because some kits have incorrect expiration dates printed on their labels. The recall affects products distributed worldwide, including across all U.S. states and several European countries, as well as Japan. This is a Class III recall, the most serious classification for medical devices.
- Recalling firm
- Medtronic Neuromodulation
- Product
- Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; 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 III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-13
- Status
- Open, Classified
- 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 FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d9ca49e2-7694-4cd0-aa5f-d39132a5f25a