Skintact DF27NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 19005531506388), received between Jan 26, 2016 and Feb 4, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.

• MalfunctionFeb 4, 2026Mechanical Problem

  ON JANUARY 12, 2026, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) HOSPITAL IN THE UK. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF27N AND AN UNKNOWN DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "THE MAGNET ON THE CONNECTOR RAISED SO WOULD NOT SLIP IN TO DEFIB". ADDITIONALLY, WE HAVE RECEIVED TWO PICTURES SHOWING THE CLAIMED FAILURE. ON ONE OF THE TWO PICTURES, IT IS CLEARLY VISIBLE THAT THE MAGNETIC INSERT OF THE PLUG IS PROTRUDING OUT OF ITS SOCKET. ON THE OTHER PICTURE, THE PLUG IS ONLY SEEN IN THE TOP SIGHT. NO VISUAL DAMAGES OR OTHER DEVIATIONS OF THE PLUG CAN BE SEEN ON THE CUSTOMER PICTURES. IT WAS ALSO SPECIFIED THAT THE CONCERNED SAMPLE WILL BE AVAILABLE FOR FURTHER INVESTIGATION. WE ARE THEREFORE AWAITING THE CONCERNED SAMPLE. WE WILL PROVIDE A FOLLOW UP REPORT ONCE ANY FURTHER INFORMATION WILL BECOME AVAILABLE.

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

  MAUDE report 24256049 ↗
• MalfunctionSep 13, 2016Fitting Problem; Fitting Problem; Insufficient Device Problem Information

  ON AUGUST 11TH, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE AT HOSPITAL (B)(6). AN UNKNOWN DEFIBRILLATOR AND A SKINTACT DEFIBRILLATION ELECTRODE SET (DF27N) WERE USED AT THE CARDIOLOGY INTENSIVE. THE INITIAL REPORT DISCLOSED THAT "WHEN THEY CONNECTED A PAIR OF THIS LOT ON THE EQUIPMENT THERE WAS NO DEFIBRILLATION. THEY CHANGED THE EQUIPMENT AND HAD THE SAME NO RESULT. THEY MOVED THE CABLES ON THE ELECTRODES SIDE AND HAD RESULT !" THE MALFUNCTION CAUSED NO HARM OR IMPACT TO THE PATIENT. NO FURTHER INFORMATION'S ON THE PROCEDURE AND THE GENERATOR MODEL HAVE BEEN DISCLOSED SO FAR.

  MAUDE report 5945518 ↗
• MalfunctionJan 26, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2015, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) HOSPITAL, (B)(6). AN ANGIOGRAPHY PROCEDURE WAS PERFORMED. A DEFIBRILLATION ELECTRODE SET (SKINTACT DF27N) WAS CONNECTED TO A PHILIPS HEARSTART XL DEFIBRILLATOR. THE ELECTRODES WERE APPLIED TO THE PATIENT PROPHYLACTICALLY. AFTER APPLYING THE ELECTRODES TO THE PATIENT, THE DEFIBRILLATOR HEARSTART XL GAVE AN ERROR MESSAGE WITH THE INFORMATION: "PADS FALLEN OFF." THE INVESTIGATION PROCEDURE WAS INTERRUPTED AND A REPLACEMENT DEFIBRILLATOR WAS OBTAINED, AGAIN A PHILIPS HEARSTART XL DEFIBRILLATOR. THE ELECTRODES WERE CONNECTED AND THE SAME ERROR MESSAGE WAS OBTAINED: "PADS FALLEN OFF." IN ORDER TO CONTINUE THE ANGIOGRAPHY, A PHILIPS ORIGINAL ELECTRODE M3716A (ADULT RADIOLUCENT) WAS USED. THE INVOLVED ELECTRODE WAS DISCARDED. NO FURTHER INFORMATION ON THE PATIENT, THE PROCEDURE AND THE SKIN PREPARATION HAVE BEEN DISCLOSED SO FAR. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5390072 ↗