InterStim(TM) System, Model Numbers recallZ-1774-2019 · Medtronic Neuromodulation · initiated May 15, 2019
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
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
FDA root cause category: Software design
What the company is doing
Medtronic sent an Urgent Medical Device Safety Notification letter dated May 2019, to US Physicians and European physician. The notifications were delivered by mail, personal delivery by Medtronic Representatives, fax, or equivalent method. A confirmation form will be used to document receipt and understanding of the notification, and a minimum three attempts will be made to obtain confirmation from non-responding physicians that the notification has been received and understood.
Recall details
- Recall number
- Z-1774-2019
- Status
- Open, Classified
- Initiated by the company
- May 15, 2019
- Posted by the FDA
- Jun 7, 2019
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 13979 units
- Product code
- EZW
- FDA submissions
- P970004S268, P080025S163
- Distribution
- Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands
Product description
InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).
Code information (models, lots, serial numbers)
Model Numbers/UDI: a) TH90G01/00763000058005 b) TH90GFA/00763000187231 c) TH90G02/00763000192259, 00763000192266, 00763000192273, 00763000192280, 00763000192297, 00763000192303, 00763000192310 d) TH90G03/00763000192310 ALL LOT/SERIAL NUMBERS
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- N/A TH90G01Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence2 recalls0 reports
- N/A TH90GFAMedtronic, Inc. · Stimulator, electrical, implantable, for incontinence2 recalls0 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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