Medtronic Neuromodulation: Medical Device Recall in 2019 - (Recall #: Z-1774-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).

Product Classification:

Class II

Date Initiated: May 15, 2019

Date Posted: June 19, 2019

Recall Number: Z-1774-2019

Event ID: 82626

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).

Status: Ongoing

Product Quantity: 13979 units

Code Information:

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

Distribution Pattern:

Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated