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Open, Classified

Medtronic InterStim Ground Pad REF 041826

FDA Recall Z-2365-2023 · Posted 2023-08-10

Recalling FirmMedtronic Neuromodulation
Recall StatusOpen, Classified
Product CodeEZW
Date Initiated2023-07-06
Product Quantity360 packs (36 kits of 10 packs each)

Reason for Recall

Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

International distribution to the country of Iran.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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