Skintact DF20NRecalls & reported problems
Leonhard Lang GmbH · Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 19005531501130), received between Oct 15, 2025 and Mar 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Mechanical Problem
ON (B)(6) 2026, WE HAVE BEEN INFORMED BY A CUSTOMER ABOUT A FAILURE WITH A DEFIBRILLATION ELECTRODE SET. SKINTACT DEFIBRILLATION ELECTRODES OUR MODEL DF20N HAD BEEN DETECTED AS DEFECTIVE. THE INITIAL REPORT IS STATING THAT: "THE PACKAGING BAG IS NOT SEALED." WE ALSO RECEIVED ONE PICTURE SHOWING THE CLAIMED DEFECT. REVIEWING THE CUSTOMER PICTURE IT IS VISIBLE AN UNSEALED POUCH SEALING AT THE TOP OF THE POUCH. FOR A FURTHER ROOT CAUSE ANALYSES, WE HAVE REQUESTED THE CONCERNED CUSTOMER POUCH. NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24725945 ↗MalfunctionOct 15, 2025No Apparent Adverse Event; No Apparent Adverse Event
ON SEPTEMBER 24TH, 2025, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) HOSPITAL IN (B)(6). SKINTACT DEFIBRILLATION ELECTRODES MODEL: DF20N AND AN UNKNOWN DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT STATED THAT "-ELECTRODE REPEATEDLY FAILED TO SHOCK PATIENT. PATIENT IS OF STOCKY BODY, DEFIBRILLATOR SETTING WAS MANUAL. PATIENT WAS NOT HARMED." WE HAVE REQUESTED FURTHER INFORMATION, A FILLED IN QUESTIONNAIRE BUT NONE HAVE BEEN RECEIVED SO FAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23297909 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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