CHATTANOOGA 2760Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912292740), received between Aug 15, 2016 and May 31, 2026 — classified as 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Intermittent Energy Output” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED A BURN DURING TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 25342861 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE E-STIM THERAPY IS BURNING PATIENTS, PATIENT SUSTAINED A DIME SIZED 2ND DEGREE BURN UNDER ONE ELECTRODE.

  Patient problems: Burn(s)

  MAUDE report 22929617 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE UNIT HAS BURNED PATIENT DURING INTERFERENTIAL TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 21532030 ↗
• InjuryApr 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT DURING HER E-STIM TREATMENT, SHE RECEIVED AN UNEXPECTED AND PAINFUL ELECTRICAL SHOCK. THE TENS UNIT WAS SET UP BY A FEMALE PHYSICAL THERAPY ASSISTANT. ELECTRODES WERE PLACED ON HER BODY/SKIN IN THE AREAS OF HER RIGHT AND LEFT TRAPEZIUMS MUSCLE AND HER RIGHT AND LOWER BACK MUSCLE. THE FIRST 8-10 MINUTES OF HER TREATMENT FELT SIMILAR TO OTHER TREATMENTS, WHERE SHE FELT OCCASIONAL GENTLE ELECTRICAL STIMULATION IN THE AREA OF THE ELECTRODES. AT ONE POINT DURING HER THERAPY, SHE RECEIVED A CONTINUOUS AND STRONG CURRENT/SHOCK THAT WAS VERY PAINFUL. (B)(6) WAS UNABLE TO SIT UP AND REACH OUT FOR THE MACHINE TO TURN IT OFF. AFTER ABOUT ONE MINUTE OF THE INTENSE PAIN, SHE WAS FINALLY ABLE TO SIT UP AND TURN OFF THE TENS UNIT THAT WAS SITTING OUT OF HER REACH. SHE THEN PUSHED THE CALL BUTTON. THE PATIENT DESCRIBED THE FEELING OF "SIGNIFICANT JOLTING TYPE SHOCKS" AND ALSO DESCRIBED IT AS "ONE SHOCK WHEN IT MALFUNCTIONED IT CONTINUED TO SHOCK AND MAKE ALL MY MUSCLES CONTRACT LIKE I WAS HAVING A SEIZURE BEFORE ANYONE GOT TO ME TO TURN IF OFF". THE MALFUNCTIONING TENS UNIT CAUSED THE PATIENT TO EXPERIENCE A BURN INJURY. FOLLOWING HER APPOINTMENT, (B)(6) BEGAN HAVING

  Patient problems: Burn(s)

  MAUDE report 19056512 ↗
• InjuryJun 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE THERAPIST TREATED THE PATIENT FOR INJURIES WITH A STIMULATION DEVICE AND TREATMENT TO HELP ALLEVIATE PAIN AND DISCOMFORT IN THE PATIENT'S BACK, AND ALLEGEDLY BURNED THE PLAINTIFF CAUSING SERIOUS PAIN, DISCOMFORT AND PERMANENT DISFIGUREMENT BY SERIOUSLY SCARRING ON THE PATIENT'S SHOULDER.

  Patient problems: Burn(s)

  MAUDE report 17121796 ↗
• InjuryJan 25, 2023Temperature Problem; Excessive Heating; Temperature Problem; Excessive Heating

  IT WAS REPORTED THAT THE UNIT ALLEGEDLY CAUSED A 2ND DEGREE BURN TO PATIENT DURING TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 16244545 ↗
• MalfunctionJun 16, 2022Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE THE UNIT ALLEGEDLY CAUSED A SHOCK TO PATIENT DURING STIM TREATMENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 14718234 ↗
• MalfunctionApr 8, 2021Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT "IT IS BELIEVED TO HAVE RECEIVED BURNS DURING ELECTRICAL STIMULATION TREATMENT. THE UNIT REPORTEDLY RAMPED UP INTENSITY ON ITS OWN." DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME. MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: Burn(s)

  MAUDE report 11634000 ↗
• MalfunctionMar 25, 2021Overheating of Device; No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENTS HAVE ALLEGEDLY SUSTAINED BURN INJURIES AS A RESULT OF THE DEVICE OVERHEATING.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567525 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INTERFERENTIAL TREATMENT, THE CUSTOMER ALLEGEDLY RECEIVED AN OVERCHARGE AND REPORTED A SECOND DEGREE BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11313233 ↗
• MalfunctionJul 27, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT "THE DEVICE STARTED TO SMOKE AND IT STOPPED WORKING." NO INJURY WAS REPORTED. DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME. MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10326534 ↗
• MalfunctionJun 4, 2020Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT "WHEN INCREASING THE VOLTS, THE DISPLAY RESETS AND DECREASES VOLTAGE AND A PATIENT COMPLAINED OF A SHOCK." THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF THE DEVICE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVALUATION.

  Patient problems: Electric Shock

  MAUDE report 10118254 ↗
• MalfunctionFeb 24, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE UNIT WAS OVERHEATING. THE PATIENT FELT THE APPLICATOR WAS HOT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9744952 ↗
• MalfunctionSep 25, 2019Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT DURING RUSSIAN TREATMENT THE UNIT INCREASES INTENSITY AND SHOCKS PATIENTS, THEN IT SHUTS OFF. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Electric Shock

  MAUDE report 9117431 ↗
• InjuryAug 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER 21CFR PART 803, AN MDR REPORTABLE EVENT. COMPLAINT RECEIVED THAT ALLEGES I WAS BEING TREATED AT A PHYSICAL THERAPY OFFICE AND HAD TWO ELECTRODES PUT ON MY LEFT HIP AREA FOR TROCHANTERIC BURSITIS. AFTER THE STIMULATOR MACHINE WAS ON FOR ABOUT ONE MINUTE, I STARTED GETTING VERY EXCRUCIATING SORENESS IN THE TREATED AREA. SINCE IT WAS ON FOR ONLY TEN MINUTES, I DID NOT MAKE A CONNECTION WITH THE SEVERE BURN THAT RESULTED. WHEN MY THERAPIST CAME BACK IN THE ROOM, THE ELECTRODES WERE REMOVED AND WHEN THE THERAPIST WENT TO MASSAGE THE AREA, THE THERAPIST ASKED IF I KNEW I HAD SOME TYPE OF PRESSURE SORE AND DID I HAVE ANY ITCHING, SORENESS OR AWARENESS OF THE "LESION" THAT WAS NOTICED. I WENT TO MY PRIMARY CARE DOCTOR WHO REFERRED ME TO A DERMATOLOGIST. TODAY, (B)(6) 2016, THE DERMATOLOGIST SAID IT HAD NOT HEALED AT ALL AND DID A BIOPSY. I ALSO HAD MY PHYSICAL MED REHAB DOCTOR CHECK IT OUT AND AS SOON AS HE SAW THE "LESION/BURN/SORE", HE SAID I WAS BURNED BY THE ELECTRODE. TO DATE, EVEN THOUGH I WAS TOLD IT IS NOT INFECTED, I WAS GIVEN AN ANTIBIOTIC OINTMENT TO PUT ON ONCE A DAY. THAT DID NOT WORK MUCH AT ALL, JUST A SLIGHT DECREASE IN SIZE OF WOUND. AT THIS POINT I DO NOT KNOW WHAT TO

  Patient problems: Lead(s), Burn(s) From

  MAUDE report 5875609 ↗