Recall Z-0998-2022— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2022-02-28. FDA's recall record names no specific 510(k) clearance for this event. 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) InterStim x "My Therapy" Patient Therapy Application Software, Model Number A52300. Reason: 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..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-28
- Firm location
- Minneapolis, MN, United States
Product description
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) InterStim x "My Therapy" Patient Therapy Application Software, Model Number A52300
Reason for 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.