Medtronic Neuromodulation has recalled 211 units of the InterStim Smart Programmer and Communicator Kits, specifically model TH90Q01. A defect in a subset of the handsets (Model HH90) prevents them from completing the pairing process with the communicator (TM90) during initial setup. This failure means the device cannot be used as intended to program or communicate with the implanted neuromodulation system. Consumers should check their serial numbers and contact their healthcare provider or Medtronic for assistance.
The handset and communicator may fail to connect, preventing the patient or clinician from adjusting or monitoring the implanted device. This technical failure can delay therapy or prevent necessary adjustments to the treatment of bladder or bowel control conditions.
Healthcare provider or manufacturer coordination
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.