Reported Sep 18, 2024 · Ongoing

Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the…

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?

  • Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
Lot codes and dates
  • GTIN 0076300092754
  • serial numbers

    211 of 211 codes

    • NPV0082351
    • NPV0085575
    • NPV0082308
    • NPV0082309
    • NPV0082314
    • NPV0082328
    • NPV0082329
    • NPV0082349
    • NPV0082412
    • NPV0082483
    • NPV0082494
    • NPV0082608
    • NPV0082631
    • NPV0082646
    • NPV0082684
    • NPV0082689
    • NPV0082690
    • NPV0082691
    • NPV0082756
    • NPV0082866
    • NPV0082869
    • NPV0082899
    • NPV0082921
    • NPV0083001
    • NPV0083071
    • NPV0083084
    • NPV0083116
    • NPV0083125
    • NPV0083171
    • NPV0083507
    • NPV0083577
    • NPV0083629
    • NPV0083632
    • NPV0083853
    • NPV0083883
    • NPV0083917
    • NPV0083944
    • NPV0083948
    • NPV0083954
    • NPV0083972
    • NPV0084077
    • NPV0084084
    • NPV0084104
    • NPV0084113
    • NPV0084119
    • NPV0084125
    • NPV0084177
    • NPV0084211
    • NPV0084253
    • NPV0084283
    • NPV0084293
    • NPV0084295
    • NPV0084304
    • NPV0084305
    • NPV0084311
    • NPV0084312
    • NPV0084313
    • NPV0084317
    • NPV0084330
    • NPV0084340
Amount recalled
211 devices

Where it was sold

  • Nationwide

Why it was recalled

A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.