Medtronic InterStim Clinician Software Has Data Loss Anomaly Affecting Patient Information
The InterStim X Clinician software used to program urinary incontinence therapy has a software bug that causes patient information to be lost and display a 'Data Lost' notification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a medical device therapy system where a software anomaly causes patient information to not be retained. Although no illnesses or injuries have been reported, the system is used to administer electrical stimulation therapy, and data loss represents a potential risk to patient care.
Plain-English summary
Medtronic Neuromodulation is recalling certain handset models and software applications of the InterStim Therapy System for Urinary Control due to a software anomaly. The InterStim X Clinician software application, which is used by healthcare providers to program and adjust therapy, has a bug that prevents patient information entered in the Patient Information fields from being retained. When this occurs, a 'Data Lost' notification is displayed.
The recalled equipment includes five handset models (TH90Q01, TH90QFA, TH90PFA, TH90GFA, TH90G01) with specific serial numbers, as well as the InterStim X Clinician Therapy Application Software (Model A51300) and InterStim X 'My Therapy' Patient Therapy Application Software (Model A52300). The system is used to provide electrical stimulation therapy to treat urinary incontinence.
Approximately 1,005 units were distributed nationwide across 28 U.S. states including Florida, Illinois, Wisconsin, Texas, California, and others.
The recalled product
- Product
- MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) Inte
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- data-loss
- software-bug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) Model Numbers: 1) TH90Q01
- UDI-Device Identifier (GTIN/UPN) 00763000582470
- Serial Numbers: NPF0000074
- NPF0000075
- NPF0000096
- NPF0000097
- NPF0000109
- NPF0000197
- NPF0000238
- NPF0000263
- NPF0000264
- NPF0000270
- NPF0000271
- NPF0000284
- NPF0000292
- NPF0000379
- NPF0000414
- NPF0000422
- NPF0000440
- NPF0000458
Distribution
Distributed nationwide across the United States.
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