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Kendall 40000006 (UDI 20192253017745)Recalls & reported problems

Cardinal Health 200, LLC · Kendall 1710H defibrillation electrode · Class 3

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20192253017745), received between Mar 17, 2022 and Mar 17, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Device problems

  • Detachment of Device or Device Component3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT THEY HAD A CODE ON (B)(6) 2022 AND AFTER SHOCKING THE PATIENT WITH THE DEFIBRILLATOR, THE WIRE DISLODGED FROM THE DEFIBRILLATOR PAD. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13791952 ↗
  • MalfunctionMar 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT THE TEAM IN PACEMAKER ATTACHED A PAIR OF DEFIBRILLATOR PADS TO THEIR PATIENT AND WITHOUT THE PATIENT MOVING, OR ANY SHOCKING BY THE DEFIBRILLATOR, THE WIRE DISCONNECTED FROM THE PADS. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13791941 ↗
  • MalfunctionMar 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT THE PATIENT WAS HAVING AN ICD LEAD REVISION AND DURING THE PROCEDURE THE PATIENT REQUIRED CARDIO VERSION X2 AND DEFIBRILLATION X2. AFTER THE FIRST DEFIBRILLATION IT WAS FOUND THAT THE PACING PAD LEAD RHYTHM WAS ABSENT ON THE PHILLIPS MONITOR. THE PACING LEAD ATTACHED TO THE PAD ON THE PATIENT'S BACK HAD DISLODGED FROM THE PAD. NEW PADS WERE QUICKLY APPLIED AND THE SECOND DEFIBRILLATION WAS EFFECTIVE WITH NEW PADS. THE PATIENT WAS NOT HARMED BUT IT WAS A CLOSE CALL. THE PATIENT RESPONDED WELL TO DEFIBRILLATION AND THERE WAS NO UNEXPECTED OR PROLONGED CARE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13791860 ↗

Other Automated external defibrillators (non-wearable) devices

All Automated external defibrillators (non-wearable) devices →

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