CHATTANOOGA 2738Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888912021883), received between Dec 13, 2016 and Aug 14, 2025 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SUSTAINED DERMAL BURNS DURING COMBO MODALITY, NO ERROR MESSAGE RECEIVED ON THE DEVICE.

  Patient problems: Burn(s)

  MAUDE report 22812228 ↗
• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE ALLEGEDLY CAUSED PAIN AND A BURN TO THE PATIENT DURING TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 16449097 ↗
• MalfunctionSep 2, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT ALLEGEDLY THE DEVICE INTENSITY RAMPED UP DURING STIM TREATMENT.

  Patient problems: Burn(s); Electric Shock

  MAUDE report 15351673 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE ALLEGEDLY CAUSED A CRACKLING NOISE, SMOKE FROM AN ELECTRODE AND RESULTED IN A 3RD DEGREE BURN TO THE PATIENT THAT WAS BEING TREATED.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 15298433 ↗
• MalfunctionMar 30, 2022Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE DEVICE ALLEGEDLY CAUSED AN UNEXPECTED SHOCK TO THE PATIENT WHEN THE DEVICE EXPERIENCED A SUDDEN FREQUENCY JUMP. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR ADVERSE EVENT.

  Patient problems: Electric Shock

  MAUDE report 13956061 ↗
• MalfunctionMar 18, 2022Output above Specifications

  IT WAS REPORTED THAT THE DEVICE ALLEGEDLY CAUSED AN UNEXPECTED SHOCK TO THE PATIENT WHEN THE DEVICE EXPERIENCED A SUDDEN FREQUENCY JUMP. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR ADVERSE EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 13805735 ↗
• InjuryMar 18, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE UNIT ALLEGEDLY BURNED THE PATIENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 13805734 ↗
• MalfunctionDec 9, 2021Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE DEVICE ALLEGEDLY EXPERIENCED A SPIKING INTENSITY AND THEN STOPPED WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12973125 ↗
• InjuryMar 10, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY HAD TO UNDERGO A SURGERY ON HER SHOULDER AFTER TREATMENT OF ELECTRIC STIMULATION AT THE PHYSICAL THERAPY CLINIC.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11457270 ↗
• MalfunctionJun 4, 2020Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT PATIENTS HAD EXPERIENCED A SHOCK/BURNING SENSATION DURING TREATMENT. 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 10118255 ↗
• MalfunctionDec 23, 2019Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT THE UNIT EXPERIENCED "LITE SHOCKING INTENSITY SKIPS, ISSUE WITH ENCODER AND KNOB NO ERROR CODES" DURING TREATMENT. THERE WAS REPORTEDLY NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9510520 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED WHILE ON ELECTROTHERAPY TREATMENT. PATIENT GOT A BLISTER THAT WAS TREATED IMMEDIATELY. UNIT DID NOT DISPLAY ANY ERROR CODES. UNIT WAS JUST RECENTLY INSPECTED AND CAME BACK WITH EVERYTHING WORKING FINE. CUSTOMER WAS NOT AWARE WHEN WAS THE LAST TIME LEAD WIRE AND ELECTRODES WERE CHANGED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8959563 ↗
• MalfunctionJul 10, 2019Electrical /Electronic Property Problem; Sparking; Electrical /Electronic Property Problem; Sparking

  IT WAS REPORTED THAT THE UNIT WAS "NOT ALWAYS TURNING ON OR SHUTTING OFF UNEXPECTEDLY... THE UNIT HAS A POWER SURGE AND CAUSING A SPARK AT THE ELECTRODE, NO PATIENT WAS INJURED." THIS REPORTEDLY OCCURRED DURING TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 8775280 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED BY THE ELECTRODES WHILE USING THE TRANSPORT UNIT. PICTURES INDICATE A SECOND-DEGREE BURN. FURTHER INFORMATION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8734872 ↗
• InjuryMar 1, 2017High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Adverse Event Without Identified Device or Use Problem

  COMPLAINT RECEIVED THAT ALLEGES "PATIENT,"WAS ON THE MACHINE FOR APPROX. 15 MINUTES WITHOUT INCIDENT AND THERE WAS A SUDDEN SURGE THAT SHOT THE ELECTRODE OFF OF HIS LEG. WHEN SHE LOOKED AT HIS LEG HE HAD WHAT APPEARS TO BE 3RD DEGREE ELECTRICAL BURNS UNDERNEATH". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.

  Patient problems: Full thickness (Third Degree) Burn; Lead(s), Burn(s) From

  MAUDE report 6368197 ↗
• InjuryDec 13, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT RECEIVED THAT ALLEGES "SCREEN WILL NOT LIGHT UP, CURRENT IS NOT STEADY BURNED A PATIENT WHO LATER HAD SKIN GRAFTS". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.

  Patient problems: Burn, Thermal

  MAUDE report 6171096 ↗