Medtronic Neuromodulation: Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Recall Summary Medtronic is recalling certain 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 affected kits were distributed worldwide, including throughout the United States and several European and Asian countries. Users of these devices should check their product labeling to determine if they have an affected kit.
- 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 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/3ab324fc-5843-4e75-bf81-da2c961f8f26