TENS 7000 Rechargeable DT7303Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00092237623756), received between Feb 13, 2024 and Aug 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2025Human-Device Interface Problem; Human-Device Interface Problem

  CUSTOMER SAID HE HAS BURN/BLACK MARKS WHERE THE ELECTRODES WERE ON HIS BODY. NO DOCTOR APPROVAL WAS RECEIVED AS THIS WAS AN OTC DEVICE AND PREVIOUS BURNS IS NOT LISTED AS A CONTRAINDICATION. CUSTOMER SAID I HAVE USED PREVIOUS ELECTRODES AND TENS UNITS WITHOUT ISSUE. PER TWF: PRE-EXISTING CONDITIONS IS "PREVIOUS BURNS, HEALED, AT AREA". BIPHASIC RECTANGULAR, MODULATED WAVEFORM - 100 HZ @ 300 S PULSE WIDTH USING 2X2" SELF ADHESIVE ELECTRODES ON LEFT UPPER ARM 5" APART, 2 IN TOTAL. WHEN ASKED IF NEW OR USED, CUSTOMER STATES "YES". STATES BURNS APPEARED IMMEDIATELY, REMOVED DUE TO SENSATION OF BURNS, ON GOING.HE DID SEEK MEDICAL ATTENTION. STATES ELECTRODES USED "0" TIMES PREVIOUSLY. STATES ELECTRODES STORED IN THE ORIGINAL PACKAGING BETWEEN 41-86F AND 40-70% HUMIDITY. ROOM AIR. STATES ELECTRODES WERE.5" APART, NO KNOWN ALLERGIES. 300US WIDTH, 100HZ RATE. USING TENS 7000 BRAND ELECTRODES. HAS NOT TRIED NEW LEADS, SHOW NO DAMAGE. THE ORIGINAL BURNS WERE CAUSED BY A HOUSE FIRE IN 2013.THE TISSUE, AT TIME OF USE, WAS HEALED AND HAS BEEN FOR ~ 7 YEARS. 2. WERE THE ELECTRODES 5" APART OR.5"? 0.5." 3. WERE THE ELECTRODES 100% ADHERED TO THE SKIN WHEN YOU WERE USING THEM? YES.USER MANUAL ATTA

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22693802 ↗
• MalfunctionFeb 13, 2024

  COMPASS HEALTH BRANDS OF MIDDLEBURG, OH MAKES A TENS 7000 RECHARGEABLE MEDICAL DEVICE (ITEM DT7303). THE ON/OFF BUTTON AND START/STOP BUTTON ARE ONE SINGLE BUTTON AND THAT BUTTON FREQUENTLY MALFUNCTIONS LEAVING THE UNIT EITHER STUCK IN ON OR OFF MODE WITH NO WAY TO ALTER IT UNTIL THE BATTERY ON THE UNIT DIES. I HAVE EXPERIENCED THIS MULTIPLE TIMES. IT IS PROBLEMATIC WHEN IT IS STUCK IN THE OFF MODE BECAUSE THEN I CAN'T USE THE DEVICE FOR MANY HOURS FOR TREATMENT. IT IS MORE PROBLEMATIC WHEN IT IS STUCK IN THE ON MODE BECAUSE I THEN HAVE TO REMOVE THE TENS ELECTRODES MID-USAGE WHICH IS PAINFUL AND I FEAR IT COULD BE DANGEROUS TO ME AND TO THE UNIT. PRESSING AND HOLDING THE BUTTON NORMALLY SHUTS THE DEVICE DOWN, BUT OFTEN RESULTS IN THE SCREEN GOING BLANK, BUT THE BACKLIGHT REMAINING ON. AT THIS POINT, NONE OF THE CONTROLS SEEM TO HAVE ANY EFFECT ON THE UNIT, ALTHOUGH IT WILL STILL BEEP (WHAT THE BEEP SIGNIFIES IS NOT KNOWN, BECAUSE THE UNIT DOESN'T SEEM TO ACT ANY DIFFERENTLY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704288 ↗