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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Medtronic Neuromodulation: InterStim Smart Programmer Kits Recalled for Pairing Failure

Agency Publication Date: September 6, 2024
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Summary

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.

Risk

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.

What You Should Do

  1. Check your InterStim Smart Programmer kit (Model TH90Q01) for the GTIN 0076300092754 and verify the serial number on the handset or packaging.
  2. Verify if your serial number is among the affected units: 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, NPV0084353, NPV0084355, NPV0084428, NPV0084473, NPV0084523, NPV0084610, NPV0084634, NPV0084679, NPV0084681, NPV0084695, NPV0084697, NPV0084751, NPV0084753, NPV0084754, NPV0084767, NPV0085004, NPV0085034, NPV0085036, NPV0085057, NPV0085059, NPV0085077, NPV0085081, NPV0085473, NPV0085510, NPV0085529, NPV0085580, NPV0085601, NPV0085616, NPV0085626, NPV0085631, NPV0085647, NPV0085653, NPV0082276, NPV0082278, NPV0082281, NPV0082304, NPV0082313, NPV0082316, NPV0082320, NPV0082340, NPV0082352, NPV0082358, NPV0082376, NPV0082377, NPV0082418, NPV0082421, NPV0082431, NPV0082450, NPV0082451, NPV0082476, NPV0082480, NPV0082508, NPV0082513, NPV0082514, NPV0082520, NPV0082524, NPV0082537, NPV0082539, NPV0082543, NPV0082559, NPV0082562, NPV0082569, NPV0082571, NPV0082572, NPV0082591, NPV0082635, NPV0082666, NPV0082674, NPV0082695, NPV0082701, NPV0082722, NPV0082723, NPV0082740, NPV0082769, NPV0082779, NPV0082782, NPV0082789, NPV0082806, NPV0082859, NPV0082871, NPV0082879, NPV0082882, NPV0082897, NPV0082913, NPV0082915, NPV0082916, NPV0082923, NPV0082928, NPV0082931, NPV0082944, NPV0082945, NPV0082949, NPV0082952, NPV0082960, NPV0082963, NPV0083005, NPV0083027, NPV0083036, NPV0083047, NPV0083052, NPV0083053, NPV0083104, NPV0083129, NPV0083134, NPV0083175, NPV0083178, NPV0083189, NPV0083192, NPV0083200, NPV0083225, NPV0083228, NPV0083229, NPV0083230, NPV0083237, NPV0083277, NPV0083289, NPV0083302, NPV0083312, NPV0083329, NPV0083332, NPV0083344, NPV0083345, NPV0083349, NPV0083371, NPV0083396, NPV0083484, NPV0083506, NPV0083522, NPV0083526, NPV0083555, NPV0083575, NPV0083596, NPV0083604, NPV0083613, NPV0083618, NPV0083646, NPV0083649, NPV0083688, NPV0083708, NPV0083712, NPV0083716, NPV0083729, NPV0083738, NPV0083827, NPV0083842, NPV0083845, NPV0083846, NPV0083847, NPV0083859, NPV0083937, or NPV0084126.
  3. If your kit contains an affected handset, contact your healthcare provider or Medtronic Neuromodulation for further instructions and information on a potential replacement.
  4. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer coordination

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: InterStim Smart Programmer and Communicator Kits (Model TH90Q01)
Model / REF:
TH90Q01
HH90
TM90
UPC Codes:
0076300092754
Lot Numbers (211):
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95131
Status: Active
Manufacturer: Medtronic Neuromodulation
Sold By: Authorized Medical Distributors; Hospitals; Specialty Clinics
Manufactured In: United States
Units Affected: 211 devices
Distributed To: Nationwide

Were You Affected by This Recall?

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.

Find an Attorney

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.