Recalls / —
—#202208
Product
Medtronic InterStim Ground Pad REF 041826
- FDA product code
- EZW — Stimulator, Electrical, Implantable, For Incontinence
- Device class
- Class 3
- Medical specialty
- Gastroenterology, Urology
- PMA numbers
- P070004S001, P080025
- Affected lot / code info
- Product Number: 041826; UDI: 20763000343273; Lot Number: 60347246
Why it was recalled
Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
The consignee recall notification was sent out via mail on 07/06/2023. The letter instructs the consignee to return any affected product they may have, and to forward the notification to those who need to be aware within the organization or to any location which the devices have been transferred. Consignee also asked to complete and return a confirmation.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568
Distribution
- Distribution pattern
- International distribution to the country of Iran.
Timeline
- Recall initiated
- 2023-07-06
- Posted by FDA
- 2023-08-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #202208. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.