Medtronic InterStim System Recall: Unexpected Stimulation Risk
Medtronic recalls InterStim systems with model numbers TH90G01, TH90GFA, TH90G02, TH90G03 due to potential unexpected stimulation during programming. Affected users should contact Medtronic for details.
Lower-risk recall
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
Contact the company
What happened, in plain English
Medtronic is recalling specific models of InterStim systems that may cause unexpected stimulation during programming. This could lead to discomfort or other issues if the device is used incorrectly. Read more at govinfonow.com/recall/67924-medtronic-interstim-system-recall-unexpected-stimulation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/67924-medtronic-interstim-system-recall-unexpected-stimulation-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1774-2019
Cite this page
“Medtronic InterStim System Recall: Unexpected Stimulation Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67924-medtronic-interstim-system-recall-unexpected-stimulation-risk. Based on FDA recall #Z-1774-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1774-2019%22&limit=1).
Why it’s dangerous
The A10 Clinician Application (on Medtronic's smart programmer) may cause unexpected increases in stimulation when programming the InterStim system. This could lead to discomfort or other issues if the device is not used correctly.
Who’s affected
Users of the InterStim system with model numbers TH90G01, TH90GFA, TH90G02, or TH90G03 are affected. Patients receiving sacral neuromodulation therapy are most at risk.
How to tell if you have this one
Check if your InterStim system has model numbers TH90G01, TH90GFA, TH90G02, or TH90G03. The product was sold with the Medtronic Model A510 Clinician application.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Contact Medtronic
Reach out to Medtronic directly to confirm if your specific model is affected and get instructions on next steps.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1774-2019 (May 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1774-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.