Kendall 40000006 (UDI 20884527008435)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884527008435), received between Aug 9, 2019 and Feb 5, 2020 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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 5, 2020Product Quality Problem; Difficult or Delayed Separation; Product Quality Problem; Difficult or Delayed Separation

  THE CUSTOMER REPORTED THAT THERE IS NOT ENOUGH ADHESIVE PROPERTIES ON THE PAD LEAVING THE ADHESIVE RING TO BE INSUFFICIENT. THEY ALSO STATED THAT THE CONNECTION IS EXTREMELY SECURE SO IT IS DIFFICULT TO DETACH THE PATIENT PADS FROM THE DEFIBRILLATOR CABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9671216 ↗
• MalfunctionFeb 5, 2020Product Quality Problem; Difficult or Delayed Separation; Product Quality Problem; Difficult or Delayed Separation

  THE CUSTOMER REPORTED THAT THERE IS NOT ENOUGH ADHESIVE PROPERTIES ON THE PAD LEAVING THE ADHESIVE RING TO BE INSUFFICIENT. THEY ALSO STATED THAT THE CONNECTION IS EXTREMELY SECURE SO IT IS DIFFICULT TO DETACH THE PATIENT PADS FROM THE DEFIBRILLATOR CABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9671100 ↗
• DeathAug 9, 2019Off-Label Use; Off-Label Use

  THE CUSTOMER REPORTED, A HEALTH CARE PROVIDER ATTEMPTED TO USE A DEFIBRILLATOR PAD WITH THE WRONG AUTOMATIC EXTERNAL DEFIBRILLATOR (AED) MACHINE AND THE PATIENT EXPIRED AS A RESULT. ADDITIONALLY, THE CUSTOMER STATED THE ISSUE WAS USER ERROR AND NOT THE PRODUCT. THE NURSE CONNECTED THE INCORRECT DEFIBRILLATOR PAD TO THE DEFIBRILLATOR. THE PAD WAS CLEARLY MARKED ON THE PACKAGE AND THE NURSE DID NOT SEE IT.

  Patient problems: Death

  MAUDE report 8878277 ↗