Icy Hot SmartRelief SmartRelief 1.0 - Back/Hip KitRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00041167080450), received between Apr 24, 2020 and Apr 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2020Therapeutic or Diagnostic Output Failure

  THE TENS UNIT DOESN'T WORK PROPERLY, AND IN RESEARCHING IT, THIS SEEMS TO BE A COMMON OCCURRENCE WITH THE ICYHOT SMART RELIEF SYSTEM. YOU ARE TO SNAP THE POWER UNIT ONTO ADHESIVE PAD, BUT WHILE ONE SNAPS AND GOES ON FINE, THE OTHER SIDE DOESN'T MATCH UP QUITE RIGHT SO YOU HAVE TO MOVE IT AROUND A LITTLE TO GET IT TO SNAP ON. THIS PUT A SMALL WRINKLE IN THE PAD BY BOTH SNAPS, VERY SLIGHTLY. WHEN YOU PLACE THE PAD ON THE BACK OR HIP, INSTEAD OF THE STIMULATION OF NERVES THAT SHOULD BE FELT, THERE IS A THUMPING FEELING LIKE SOMEONE TAPPING FINGER ON YOU COUPLED WITH INTERMITTENT STIMULATION SENSATION. TRYING TO USE THE BUTTON TO INCREASE TO THE 63 SETTINGS ALSO DOESN'T WORK BECAUSE IT FEELS LIKE THE THUMPING TAKES THE SETTING I TRIED TO USE BACK DOWN TO ZERO OVER AND OVER. I HAVE TRIED THIS 3 TIMES TODAY AND EACH TIME THIS HAS HAPPENED. THIS IS THE MAIN COMPLAINT WITH THIS TENS SYSTEM IN READING REVIEWS ON VARIOUS PLACES, THAT THE UNIT ELECTRODE AND POWER SYSTEM DOESN'T WORK CORRECTLY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10000746 ↗