Z-2365-2023Class II

Medtronic InterStim Ground Pad REF 041826

Name: Z-2365-2023 Medtronic InterStim Ground Pad REF 041826
Creator: Medtronic Neuromodulation
Published: 2023-07-06
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2023-07-06 / Open, Classified / root cause: labeling and UDI

FDA source

Medtronic Neuromodulation began a recall of Medtronic InterStim Ground Pad REF 041826 on 2023-07-06. FDA classified it as Class II and gives the reason as "Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2365-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-06
Posted: 2023-08-10
Recalling firm: Medtronic Neuromodulation
Product: Medtronic InterStim Ground Pad REF 041826
Product code: EZW Stimulator, Electrical, Implantable, For Incontinence
Reason for recall: Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
Root cause tag: labeling and UDI
FDA 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 in commerce: 360 packs (36 kits of 10 packs each)
Distribution: International distribution to the country of Iran.
Product codes and lots: Product Number: 041826; UDI: 20763000343273; Lot Number: 60347246

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2365-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2365-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-10

Product code EZW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)