Skintact T-VO01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 19005531505480), received between May 16, 2024 and Jul 16, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2026Insufficient Device Problem Information

  ON (B)(6) 2026, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL TVO01) HAD BEEN USED AT HERZPRAXIS (B)(6). THE INITIAL REPORTER INFORMED LEONHARD LANG ABOUT A PATIENT INCIDENT. IT WAS STATED: "A CARDIOLOGY PRACTICE HAS COMPLAINED THAT PATIENTS FREQUENTLY REPORT ITCHING AND REDNESS FROM THE ELECTRODES, WHICH CAN REMAIN VISIBLE FOR DAYS. TWO PATIENTS EVEN DEVELOPED BLISTERS ON THEIR SKIN." ON (B)(6) 2026 WE HAVE RECEIVED A FILLED IN QUESTIONAIRE. A 48-HOUR ECG MONITORING WAS PERFORMED. THE PATIENT WAS DESCRIBED AS SLIM AND THE PATIENT SKIN WAS DESCRIBED AS NORMAL, "RATHER DRY, BODY HAIR? NO TATTOOS". A MORTARA H12+ ECG DEVICE AND MEDILAN CABLES HAVE BEEN USED. 7 ECG ELECTRODE HAVE BEEN APPLIED ON THE PATIENT'S CHEST. THE SKIN PREPARATION WAS DESCRIBED AS CLEANED WITH "ALCOHOL ISOPROPYLICUS PROPAN-2-OL", SHAVEN? DISINFECTED WITH "ALCOHOL ISOPROPYLICUS PROPAN-2-OL", NO OINTMENT HAS BEEN USED BUT THE SKIN WAS DRIED. IT WAS ALSO REPORTED THAT " THE ADHESIVE STRENGTH IS GOOD, BUT SKIN REACTION IS A PROBLEM." THE ELECTRODES ADHERED WELL AND WERE NOT REPOSITIONED. ON (B)(6) 2026 WE HAVE RECEIVED FURTHER INFORMATION AND TWO PICTURES SHOWING THE P

  Patient problems: Localized Skin Lesion; Skin Inflammation/ Irritation

  MAUDE report 25835655 ↗
• InjuryDec 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES AT (B)(6) HOSPITAL, (B)(6). SKINTACT ELECTRODES MODEL TVO01 WERE USED. THE INITIAL REPORTER STATED THAT "WE USE YOUR SKINTACT T-VO01 ELECTRODES FOR EVENT MONITORING AND HAVE AROUND 7 PATIENTS PER WEEK. IN THE LATEST MONTHS WE HAVE SEEN AN INCREASE IN PATIENTS WHO DEVELOP SKIN RASHES AND CAN'T CONTINUE USING THE ECG-DEVICE BECAUSE OF IT. THESE ARE PATIENTS WITH NO PREVIOUSLY KNOWN SKIN CONDITIONS. I'M WONDERING IF THERE MAY HAVE BEEN A CHANGE IN MANUFACTURING THE SKINTACT ELECTRODES THAT MAY GIVE THESE RESULTS? (ONE OF OUR CURRENT LOT NUMBERS ARE 250313-0245 WITH GTIN 19005531505480). SINCE WE HAVE A PROCUREMENT DEPARTMENT AT THE HOSPITAL, WE'RE SOMEWHAT LIMITED IN REGARD TO CHOOSING WHICH MATERIALS TO USE, BUT I WONDERING IF PERHAPS THE T-VO02 MAY BE MORE SUITABLE FOR SENSITIVE SKIN? I CAN'T SEE MUCH DIFFERENCE IN THE TYPES OF MATERIAL USED THOUGH" WE HAVE REQUESTED FURTHER INFORMATION AND RECEIVED ON (B)(6) 2025 A FILLED IN QUESTIONNAIRE. WITHIN THE QUESTIONNAIRE IT WAS STATED THAT THE INCIDENTS OCCURRED FROM "SPRING TO WINTER OF 2025" AND THAT "THIS CONCERNS >10 PATIENTS, ANSWERS BELOW ARE ON GROUP LEVEL"

  Patient problems: Blister; Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 23754998 ↗
• InjuryMay 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON APRIL 26TH, 2024, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL TVO01) HAD BEEN USED AT MID YORKSHIRE NHS TEACHING TRUST. THE INITIAL REPORTER INFORMED LEONHARD LANG ABOUT A PATIENT INCIDENT. IT WAS STATED: "I HAVE A PATIENT INCIDENT WHERE THE ELECTRODES HAVE ACTUALLY BURNT THE PATIENTS SKIN I DO HAVE PHOTOGRAPHS." ON MAY 08TH, 2024 WE HAVE RECEIVED A PICTURE SHOWING THE SKIN INJURY AND A PARTIALLY FILLED IN QUESTIONAIRE. A "24 HOUR AMBULATORY ECG" MONITORING WAS PERFORMED. THE PATIENT SKIN WAS DESCRIBED AS NORMAL. THE MEDICAL HISTORY WAS DESCRIBED AS "NO KNOWN ALLERGIES - PATIENT WAS ASKED AT THE TIME OF FITTING ". 3 ECG ELECTRODE HAVE BEEN APPLIED ON THE PATIENTS CHEST. THE SKIN PREPARATION WAS DESCRIBED AS CLEANED WITH "AMBU SKIN PREP PAD", NOT SHAVEN, DISINFECTED WITH "CLINELL 2% CHLORHEXIDINE IN 70% ALCOHOL SKIN WIPE", NO OINTMENT HAS BEEN USED AND DRIED WITH PAPER TOWEL. HOURS AFTER THE TREATMENT THE PATIENT NOTICED AT HOME IN THE "RIGHT UPPER CHEST AREA BURNING AND SORE, BLISTERS APPEARED". IT WAS DESCRIBED "PATIENT WAS SLEEPING - WOKE UP WITH A BURNING SENSATION AROUND 3 AM WHERE THE UPPER STICKER WAS PLACED". NO INFORMATIO

  Patient problems: Burn(s)

  MAUDE report 19329446 ↗