Recall Z-2365-2023 ยท EZW Stimulator, Electrical, Implantable, For Incontinence
Medtronic Neuromodulation
Medtronic InterStim Ground Pad REF 041826
| Date | Aug 10, 2023 (initiated Jul 6, 2023) |
| Status | Open, Classified |
| Reason | Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 360 packs (36 kits of 10 packs each) |
| Distribution | International distribution to the country of Iran. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.