Medtronic Neuromodulation: Medtronic 1x4 Pocket Adaptor Kit For Deep Brain Stimulation, Model 64001; 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 units have incorrect expiration dates printed on the label. The recall affects products distributed nationwide in the US and in several European countries and Japan. This is a Class II recall, meaning there is a potential health risk, though the company has not reported injuries or deaths related to this issue.
- 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 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/e06fe355-4744-4e0d-a8ce-1790cab5f04c