Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
InterStim(TM) System Recalled by Medtronic Neuromodulation Due to There is a potential for an unexpected increase...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Neuromodulation directly.
Affected Products
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).
Quantity: 13979 units
Why Was This Recalled?
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Neuromodulation
Medtronic Neuromodulation has 95 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report