FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: Medtronic InterStim Ground Pad REF 041826
- Recall number
- Z-2365-2023
- Recalling firm
- Medtronic Neuromodulation
- Product
- Medtronic InterStim Ground Pad REF 041826
- Status
- Open, Classified
- Initiated
- 2023-07-06
- Posted
- 2023-08-10
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- Product Number: 041826; UDI: 20763000343273; Lot Number: 60347246
- 510(k) numbers
- not on file
- PMA numbers
- ["P070004S001","P080025"]
- Product code
- EZW
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28