Reported Jun 19, 2019 · Ongoing
InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
| — | TH90G01 |
| — | TH90GFA |
| — | TH90G02 |
A510 | TH90G03 Product Usage: The Medtronic 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). |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 00763000058005TH90G01/00763000058005 2 00763000187231TH90GFA/00763000187231 3 00763000192259007630001922660076300019227300763000192280007630001922970076300019230300763000192310TH90G02/00763000192259, 00763000192266, 00763000192273, 00763000192280, 00763000192297, 00763000192303, 00763000192310 4 00763000192310TH90G03/00763000192310 ALL LOT/SERIAL NUMBERS - Amount recalled
- 13979 units
Where it was sold
- Nationwide
- PR
Why it was recalled
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
This product could cause temporary or reversible health problems — stop using it.
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