Medtronic InterStim System Recall for Unexpected Stimulation Increase
Medtronic is recalling InterStim System kits due to a potential for unexpected stimulation increases during programming with the A10 Clinician Application.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (neurostimulator) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Neuromodulation is recalling the InterStim System, including specific model numbers TH90G01, TH90GFA, TH90G02, and TH90G03. The recall involves 13,979 units distributed worldwide, including the United States, Puerto Rico, and several European countries. The product is a neurostimulator system used for sacral neuromodulation therapy.
The recall was initiated because there is a potential for an unexpected increase in stimulation during InterStim programming when using the A10 Clinician Application on Medtronic's smart programmer. The A510 Clinician app is intended to be used with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the neurostimulators.
Patients and clinicians using the affected InterStim System kits should contact Medtronic Neuromodulation for further instructions on how to proceed with the recall and ensure patient safety.
The recalled product
- 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 3
- Manufacturer
- Medtronic Neuromodulation
- Category
- Medical Device — Neurostimulator
- Hazard
- Affected units
- 13,979
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 00763000192266
- 00763000192273
- 00763000192280
- 00763000192297
- 00763000192303
- 00763000192310 d) TH90G03/00763000192310 ALL LOT/SERIAL NUMBERS
Distribution
Distributed nationwide across the United States.
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