INTERSTIM recallZ-2365-2023 · Medtronic Neuromodulation · initiated Jul 6, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2365-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 6, 2023
- Posted by the FDA
- Aug 10, 2023
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 360 packs (36 kits of 10 packs each)
- Product code
- EZW
- FDA submissions
- P070004S001, P080025
- Distribution
- International distribution to the country of Iran.
Product description
Medtronic InterStim Ground Pad REF 041826
Code information (models, lots, serial numbers)
Product Number: 041826; UDI: 20763000343273; Lot Number: 60347246
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- InterStim™ 041826Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence1 recall0 reports
Product lines
Other devices under the same FDA submission
48 devices cleared under P070004S001, P080025 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- INTERSTIM® 3058Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence6 deaths23,065 reports
- InterStim™ X 97800Medtronic, Inc. · Implanted electrical device intended for treatment of fecal incontinence5,930 reports
- InterStim™ Micro SureScan™ 97810Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence2,757 reports
- InterStim™ X 97800Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence1,822 reports
- INTERSTIM® II 3058Medtronic, Inc. · Implanted electrical device intended for treatment of fecal incontinence990 reports
- INTERSTIM® 3023Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence1 death147 reports
- N/A TH90G01Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence2 recalls0 reports
- N/A TH90GFAMedtronic, Inc. · Stimulator, electrical, implantable, for incontinence2 recalls0 reports
- InterStim™ SureScan™ 978B128Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence58 reports
- Verify® External Neurostimulator 353101Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence58 reports
- INTERSTIM® 3889-28Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence56 reports
- N/A RS5200Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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