InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neur
Check against the official notice below — it lists the full affected range.
Medtronic is recalling InterStim System models TH90G01, TH90GFA, TH90G02, and TH90G03 due to a potential for unexpected increase in stimulation during programming with the A510 Clinician Application on Medtronic's smart programmer. Approximately 13,979 units have been distributed worldwide, including throughout the United States, Puerto Rico, and several European countries including Germany, Switzerland, Italy, Spain, France, the United Kingdom, Norway, Denmark, Finland, and the Netherlands. All lot and serial numbers of the affected models are included in this recall.
The recall affects all serial numbers of the four model numbers listed. The source document does not specify a remedy or recommended action for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
Reason for recall: There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer). Distribution: Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands Quantity: 13979 units Lot/code info: Model Numbers/UDI: a) TH90G01/00763000058005 b) TH90GFA/00763000187231 c) TH90G02/00763000192259, 00763000192266, 00763000192273, 00763000192280, 00763000192297, 00763000192303, 00763000192310 d) TH90G03/00763000192310 ALL LOT/SERIAL NUMBERS
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.