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Lower risk Medical device recall · FDA · Published June 17, 2024

Medtronic Handset with Communicator Model TH90Q01: Pairing Issues After Setup

Medtronic recalls specific Handset with Communicator models TH90Q01 that may fail to pair with communicator during initial setup. Affected units have serial numbers listed in the recall notice.

🇺🇸 FDA recall #Z-3073-2024Medical deviceMedtronic ›
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Recalling firmMedtronic Neuromodulation7000 Central Ave Ne · Minneapolis, MN 55432-3568
✎ GovInfoNow plain-language explainer

What happened, in plain English

Medtronic is recalling a specific model of Handset with Communicator (TH90Q01) that may not pair correctly with the communicator during first setup. This issue doesn't cause injury but could prevent proper device use. Read more at govinfonow.com/recall/54813-medtronic-handset-with-communicator-model-th90q01-pairing-issues-after-setup.

Source Summary by GovInfoNow · govinfonow.com/recall/54813-medtronic-handset-with-communicator-model-th90q01-pairing-issues-after-setup · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3073-2024

Cite this page

“Medtronic Handset with Communicator Model TH90Q01: Pairing Issues After Setup.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54813-medtronic-handset-with-communicator-model-th90q01-pairing-issues-after-setup. Based on FDA recall #Z-3073-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3073-2024%22&limit=1).

Why it’s dangerous

A subset of these handsets may not complete pairing with the communicator during initial setup. This prevents the device from working properly but does not cause injury or health risks.

Who’s affected

Users of the Medtronic InterStim Smart Programmer system with the TH90Q01 model Handset and Communicator Kit are affected. Patients using this system for neurological therapy are most at risk of device malfunction.

How to tell if you have this one

Check for the model TH90Q01 on the Handset and the serial numbers listed in the recall notice (e.g., NPV0082351, NPV0082508). The product includes the HH90 Handset and TM90 Communicator.

  • Brand
    Medtronic
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Look for the model number TH90Q01 on the Handset and serial numbers from the list provided in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Jun 17, 202412. FDA classified it Class II: Sep 6, 202423. Published in FDA’s Enforcement Report: Sep 18, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to do anything if my device works?

The recall only affects specific units that may not pair correctly. If your device works normally, no action is needed.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3073-2024 (June 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3073-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA