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.
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
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.
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.
Users of the InterStim system with model numbers TH90G01, TH90GFA, TH90G02, or TH90G03 are affected. Patients receiving sacral neuromodulation therapy are most at risk.
Check if your InterStim system has model numbers TH90G01, TH90GFA, TH90G02, or TH90G03. The product was sold with the Medtronic Model A510 Clinician application.
Reach out to Medtronic directly to confirm if your specific model is affected and get instructions on next steps.
Model numbers TH90G01, TH90GFA, TH90G02, and TH90G03.
There is a potential for unexpected increases in stimulation during programming with the A10 Clinician Application.
No, the recall does not require immediate stop use; contact Medtronic for details.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1774-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1774-2019 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
