ePatch 2.5, BTH 02-02045Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI B146EP2510), received between Jul 31, 2023 and Sep 11, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Overheating of Device

  Alleged burn was initially reported on (b)(6) 2026. Patient was unable to specify whether they believed the issue was caused by the sensor or the patch, but stated the sensor was not hot. Patient was sitting and watching tv at the time of occurrence. Additional information was received on 14 August 2026 via GFE response. Patient was still unable to clarify whether they believed the burn to be from the sensor overheating or the patch. Patient described their symptoms as itchy chemical burns. Patient stated there was scarring, a red spot, and hurting. Patient stated they only experienced symptoms with one specific patch/sensor. Patient stated the monitor was warm, but enrollment shows they were sent an ePatch kit which included an ePatch sensor but not a monitor. No medical attention was sought. Additional information was received on 02 September 2026 via GFE response. Patient stated that no medical attention was sought for the skin injury or scar. Patient stated that the scar had not improved since initially reporting it on (b)(6) 2026. No further information to provide.

  Patient problems: Burn(s); Scar Tissue; Skin Inflammation/ Irritation

  MAUDE report 50734184 ↗
• InjuryJul 17, 2026Overheating of Device; Unintended Electrical Shock

  ON (B)(6) 2026, THE PATIENT REPORTED THAT THE EPATCH SENSOR ELECTROCUTED THE PATIENT, FLASHED RED, AND BECAME WARM/OVERHEATED WHILE BEING WORN. THE PATIENT WAS DRIVING AT THE TIME AND FELT A SENSATION TRAVELING FROM THE SHOULDER TO THE BICEP. NO MEDICAL ATTENTION WAS SOUGHT INITIALLY, AND NO MEDICATION WAS TAKEN. THE PATIENT REPORTED THAT SYMPTOMS IMPROVED AFTER REMOVING THE DEVICE. NO MOISTURE EXPOSURE, VISIBLE SKIN MARKS, OR UNUSUAL APPEARANCE OF THE PATCH WERE NOTED AFTER REMOVAL. THE PATIENT LATER REPORTED EXPERIENCING SPASMS AND SOUGHT MEDICAL EVALUATION. THE PATIENT'S SPOUSE RESEARCHED THE DEVICE AND MENTIONED AN ON/OFF BUTTON ON THE SENSOR. THE PATIENT STATED THAT NO SIMILAR SYMPTOMS HAD BEEN EXPERIENCED BEFORE THE ALLEGED MALFUNCTION. FOLLOW-UP REPORT RECEIVED ON 30 APRIL 2026 STATED THAT THE PATIENT CONTINUED TO EXPERIENCE SPASMS, WITH THE MOST SEVERE OCCURRING THREE DAYS EARLIER. THE PATIENT DESCRIBED TWITCHING SENSATIONS EXTENDING FROM UNDER THE RIB AREA TO THE ABDOMEN AND LEGS, ALONG WITH FREQUENT BATHROOM USE. THE PATIENT REPORTED THAT THE PATCH HAD FOLDED OVER AND STUCK TO THE DEVICE, AND THAT THE ADHESIVE APPEARED MELTED, FLEXIBLE, AND FLOPPY. AFTER REMOVAL, AN OUTLI

  Patient problems: Pain

  MAUDE report 25858176 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025, THE PATIENT WAS EXPERIENCING A BURNING AND ITCHING SENSATION FROM ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL AND EPATCH SENSOR - 2.5. THE PATIENT REPORTED THAT THE BURNING AND ITCHING SENSATION WOKE THEM UP. THE PATIENT CALLED THEIR DOCTOR AND MADE AN APPOINTMENT SINCE THE BURN AND ITCHINESS WERE GETTING PROGRESSIVELY WORSE. THE PATIENT WAS DIAGNOSED A FIRST-DEGREE BURN AND WAS PRESCRIBED LIDOCAINE AND HISTAMINE. THE PATIENT DOES NOT KNOW IF THE SENSOR OVERHEATED SINCE THEY WERE SLEEPING AT THE TIME OF THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 23315797 ↗
• InjuryOct 6, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THAT THE EPATCH SENSOR - 2.5 - CE OVERHEATED WHEN PLACED ON THE PATIENT'S CHEST. THE PATIENT CALLED THE EMERGENCY MEDICAL SERVICES (EMS). WHEN EMS ARRIVED, THEY REMOVED THE SENSOR FROM THE PATIENT'S CHEST. IT WAS NOTED THAT THE PATIENT HAD A FIRST-DEGREE BURN PER DOCTOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 23225196 ↗
• InjurySep 11, 2025Biocompatibility; Unintended Electrical Shock; Biocompatibility; Unintended Electrical Shock

  IT WAS REPORTED THAT ON (B)(6) 2025 WHILE THE PATIENT WAS SITTING DOWN IN A CHAIR NOTICED BURN MARKS ON THEIR SKIN WHILE WEARING THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL. THE PATIENT STATED THAT BURN MARKS WERE ON THE SKIN WHERE THE WIRES EXTENDED. THE PATIENT DIDN'T KNOW IF THE DEVICE EVER WAS HOTTER THAN NORMAL HOWEVER, THE PATIENT BELIEVED THAT THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL WAS THE CAUSE OF THE BURN MARKS. THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL WAS NEVER EXPOSED TO MOISTURE. THE PATIENT REPORTED THAT THEY KEPT THE BURN AREA CLEAN AND WAS GOING TO SEE THEIR DOCTOR IF THE PAIN CONTINUES. LATER THE PATIENT SAID THE PAIN FELT LIKE AN ELECTRICAL SHOCK ALONG WITH THEIR SKIN FEELING LIKE IT WAS ON FIRE. IF THE PAIN DIDN'T IMPROVE, THEY WOULD HAVE GONE TO THE EMERGENCY ROOM (ER). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025; THE PATIENT DID SEEK MEDICAL ATTENTION AND THE AREA WAS COVERED AFTER AND UNKNOWN OINTMENT WAS PLACE. THE PATIENT DIDN'T KNOW IF THE OINTMENT WAS A PRESCRIPTION, HOWEVER, THE PATIENT WAS NOT GIVEN A PRESCRIPTION AFTER SEEING THEIR DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY MEDICAL TREATMENT HOWEVER, THEY WERE UNSUCCESSFUL.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 23027675 ↗
• MalfunctionAug 11, 2025Failure to Charge; Overheating of Device; Failure to Charge; Overheating of Device

  IT WAS REPORTED THAT THE EPATCH SENSOR - 2.5 WAS GETTING REALLY HOT IN THE CHARGER AND THAT THE SENSOR WOULD NOT CHARGE OR UPLOAD DATA. THERE WAS NO INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22774112 ↗
• InjuryDec 19, 2024Overheating of Device; Unintended Electrical Shock; Overheating of Device; Unintended Electrical Shock

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE EPATCH SENSOR - 2.5 SHOCKED AND BURNT THE PATIENT AND AN INCREASE IN TEMPERATURE WAS NOTED. THE PATIENT REPORTED THAT THEY WENT TO A WALK-IN CLINIC WHERE THEY APPLIED CREAM TO THE AFFECTED AREA. THE PATIENT STATED THAT THE DEVICE WAS PLACED ORIGINALLY AT THE PRESCRIBING CLINIC AND THE SKIN PREP IS UNKNOWN.

  Patient problems: Electric Shock; Superficial (First Degree) Burn

  MAUDE report 20980921 ↗
• InjuryMar 1, 2024Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED ON 05 FEBRUARY 2024 THAT THE PATIENT WAS SHOWERING ON (B)(6) 2024 AND FELT A SHOCK IN HER ENTIRE BODY. THE PATIENT STARTED SHAKING AND THEY GOT OUT OF THE SHOWER TO MAKE SURE THEY WERE OKAY. THE PATIENT WENT BACK INTO THE SHOWER TO RINSE OFF. THE PATIENT SERVICES REP ADVISED THE PATIENT TO REMOVE THE DEVICE AND RETURN. A REPLACEMENT DEVICE WAS ORDERED. LATER ON, (B)(6) 2024, A PATIENT SERVICE SUPERVISOR CALLED THE PATIENT BACK AND ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT REPORTED THAT THEY WERE TRANSPORTED TO THE HOSPITAL DUE TO THE SHOCK. THE PATIENT DESCRIBED SHOCK AS IF SHE WAS HAVING A HEART ATTACK OR SEIZURE. IN THE EMERGENCY ROOM (ER) THE PATIENT WAS GIVEN PAIN MEDS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS PRESCRIBED FENTANYL AND ASPIRIN. ON (B)(6) 2024 THE PATIENT WAS EXPERIENCING SIMILAR SYMPTOMS TO WHAT THEY HAD EXPERIENCED ON (B)(6) 2024, AND THEY WERE NO LONGER COMFORTABLE WEARING THE DEVICE.

  Patient problems: Discomfort; Electric Shock

  MAUDE report 18820293 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THE SENSOR WAS PLACED AT THEIR DOCTOR'S OFFICE ONTOP OF HER IMPLANTED DEFIBRILLATOR. ONCE THEY GOT HOME THE PATIENT STARTED FEELING PAIN ON THEIR CHEST, LEGS, STOMACH AND STARTED EXPERIENCING A HEADACHE. THE PATIENT REMOVED THE DEVICE INSTANTLY AND WAS SUGGESTED TO SEEK MEDICAL ATTENTION. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) DUE TO SEVERE CHEST PAINS. THE DEVICE IS EXPECTED TO BE RETURNED.

  Patient problems: Chest Pain

  MAUDE report 17920944 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S PARENT REPORTED THAT ON THE FIRST DAY OF WEARING THE HOLTER MONITOR THE PATIENT WAS EXPERIENCING DISCOMFORT. ON THE SECOND DAY TINY RED DOTS WERE NOTED ON THE PATIENT'S SKIN. BY THE THIRD DAY THE PATIENT WAS IN PAIN AND THERE WAS A LARGE MARK/GASH THAT LOOKED LIKE BURNS. THE PATIENT'S PARENT REMOVED THE DEVICE AND LATER NOTICED LUMPS AND A DEVELOPING RASH THAT REQUIRED SEVERAL URGENT CARE RUNS AND A TRIP TO THE EMERGENCY ROOM (ER). THE PATIENT WAS TREATED FOR A STAPH INFECTION AND WAS PRESCRIBED TWO TYPES OF ANTIBIOTICS, ONE TOPICAL AND ANTI FUNGAL WHICH WAS ORAL FOR THREE MONTHS. THE PATIENT IS NO LONGER ON SERVICE. THE PATIENT HAS A HISTORY OF ECZEMA.

  Patient problems: Blister; Rash

  MAUDE report 17427612 ↗