PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 4, 2022 Initiated: February 28, 2022 #Z-0998-2022

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.

Details

Recalling Firm
Medtronic Neuromodulation
Units Affected
1005 units
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.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Medtronic Neuromodulation. Units affected: 1005 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2022. Severity: Moderate. Recall number: Z-0998-2022.

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