Skintact DF28NCRecalls & reported problems

Leonhard Lang GmbH · Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring · Class 3

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 19005531502458), received between May 27, 2025 and May 27, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Defective Component1
Defective Device1
Patient Device Interaction Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 27, 2025Defective Component; Defective Device; Patient Device Interaction Problem; Defective Component; Defective Device; Patient Device Interaction Problem
ON MAY 2ND, 2025, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) IN THE UK. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF28NC AND A ZOLL R SERIES PLUS DEFIBRILLATOR HAD BEEN USED. THE INITIAL MHRA REPORT (MHRA REFERENCE NUMBER: (B)(4)) WAS STATING THAT "SUSPECT SKINTACT DEFIB PADS THAT FAILED TO RECORD ECG ON THE DEFIBRILLATOR, POST SHOCK. DEVICE BEING USED WAS A ZOLL R SERIES PLUS. (COMPATIBLE CONSUMABLE)" WE HAVE REQUESTED FURTHER INFORMATION AND HAVE RECEIVED A FILLED IN CUSTOMER FORM SPECIFYING THAT IT WAS "UNABLE TO PICK UP TRACE/ECG FROM PADS". FURTHER ON IT WAS STATED ON THE FORM "QUARANTINED DEFIB & PADS. CONDUCTED A FULL ASSESSMENT AND TEST OF DEFIB (NO FAULTS FOUND)". ON THIS FORM IT WAS ALSO STATED THAT THE DEFIBRILLATION PROCEDURE LASTED FOR ABOUT 10 - 15 MINUTES. IF A SERIOUS INJURY AND MEDICAL /SURGICAL INTERVENTION WAS REQUIRED IT WAS SPECIFIED TO BE "UNKNOWN". FURTHER ON IT WAS STATED THAT THE INVOLVED DEVICE IS AVAILABLE FOR TESTING. NO FURTHER DETAILS HAVE BEEN DISCLOSED DESPITE REPEATED REQUESTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22086195 ↗

Device details

UDI-DI	`19005531502458`
Brand	Skintact
Model	DF28NC
Company	Leonhard Lang GmbH
Product code	MKJ · Automated External Defibrillators (Non-Wearable)
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 18, 2025

Device type (GMDN): Multifunction cardiac treatment electrode

An electrical conductor designed to be applied to an adult and/or paediatric patient for automatic or manual defibrillation, external pacing, and cardioversion through transmission of cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals and potentially return electrical impulses (e.g., defibrillator); it commonly will also be used for electrocardiographic monitoring. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead wires. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.