Medtronic recalls InterStim therapy systems for urinary control with software that loses patient data. Affected models include TH90Q01, TH90QFA, TH90PFA, TH90GFA, TH90G01, A51300, and A52300. Data entered in patient fields may not be retained, showing a 'Data Lost' notification.
There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed.
Medtronic is recalling its InterStim therapy systems for urinary control due to a software issue that causes patient data to be lost. This means information entered in the system may not be saved, and users will see a 'Data Lost' notification. The recall affects specific model numbers and serial numbers listed in the notice.
The software anomaly causes data entered in patient information fields to not be retained. When this happens, the system displays a 'Data Lost' notification, meaning patient information may be lost during use. This is a data issue rather than a physical hazard.
People using the InterStim therapy system for urinary control with the affected model numbers (TH90Q01, TH90QFA, TH90PFA, TH90GFA, TH90G01) and software versions (A51300, A52300) are likely affected. Patients with these devices should check their serial numbers against the list provided in the recall notice.
Check if your device has model numbers TH90Q01, TH90QFA, TH90PFA, TH90GFA, or TH90G01. Also, verify the software version is A51300 or A52300. The recall includes specific serial numbers listed in the notice.
Identify your device model number (TH90Q01, TH90QFA, TH90PFA, TH90GFA, or TH90G01) and software version (A51300 or A52300).
No, this recall is for a software issue that causes data loss, not a physical hazard. The risk is low and does not involve injury or damage.
Check your device model number and software version against the list provided in the recall notice. Affected models include TH90Q01, TH90QFA, TH90PFA, TH90GFA, TH90G01, and software versions A51300 or A52300.
The recall does not specify a remedy, so you should contact Medtronic directly for guidance on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0998-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0998-2022 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.
