FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: 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).
- Recall number
- Z-1774-2019
- Recalling firm
- Medtronic Neuromodulation
- Product
- 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).
- Status
- Open, Classified
- Initiated
- 2019-05-15
- Posted
- 2019-06-07
- Terminated
- not on file
- Reason
- There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
- Root cause
- Software design
- Action
- Medtronic sent an Urgent Medical Device Safety Notification letter dated May 2019, to US Physicians and European physician. The notifications were delivered by mail, personal delivery by Medtronic Representatives, fax, or equivalent method. A confirmation form will be used to document receipt and understanding of the notification, and a minimum three attempts will be made to obtain confirmation from non-responding physicians that the notification has been received and understood.
- Quantity
- 13979 units
- Distribution
- Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P970004S268","P080025S163"]
- Product code
- EZW
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28