Medtronic InterStim Therapy System for Urinary Control: Data Loss in Software
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/61019-medtronic-interstim-therapy-system-for-urinary-control-data-loss-in.
Source Summary by GovInfoNow · govinfonow.com/recall/61019-medtronic-interstim-therapy-system-for-urinary-control-data-loss-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0998-2022
Cite this page
“Medtronic InterStim Therapy System for Urinary Control: Data Loss in Software.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61019-medtronic-interstim-therapy-system-for-urinary-control-data-loss-in. Based on FDA recall #Z-0998-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0998-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Device Model
Identify your device model number (TH90Q01, TH90QFA, TH90PFA, TH90GFA, or TH90G01) and software version (A51300 or A52300).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 28 states.
FDA distribution: “US Nationwide distribution in the states of FL, IL, WI, TX, CA, ND, NC, KY, AR, MO, MN, OH, CO, KS, MS, SC, LA, WA, PA, IN, SD, MI, WV, AL, GA, TN, VA, IA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, North Carolina, North Dakota, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months 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.
Questions people ask
Is this recall dangerous?
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.
Similar recalls
Latest medical device recalls
Keep exploring
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-0998-2022 (February 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0998-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.