Covidien Defibrillation Electrodes: FDA Class 1 Safety Alert

Covidien Components of Defibrillators May Cause Organ Failure, Strokes or Death

The FDA has issued a Class 1 safety alert for the electrodes used in defibrillator medical devices listed below. A Class 1 alert is the most serious issued by the FDA.

The concern is that devices using Covidien electrodes may delay or fail to activate the electrical shock used to restart the heartbeat of patients during heart attacks, leading to strokes, organ failure or death. Reports of the delay when trying to restart the hearts of two patients resulted in one death.

  • Covidien electrodes – All Lot Numbers
    • 22660R – Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes Radiotransparent
    • 22660PC – Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes Pre-connect
    • 20660 – Kendall Adult Multi-Function Defibrillation Electrodes
    • 40000006 – Kendall 1710H Multi-Function Defibrillation Electrodes
  • Electrodes produced by Covidien and distributed under the following brands also have the same connector compatibility issue – All Lot Numbers
    • MC1710H – MediChoice Multifunction Electrode
    • M3718A – Philips HEARTSTART Multifunction Electrode Pads

Manufacturing and Distribution Dates: September 1, 2012 to August 24, 2014. The primary users of these devices are hospitals and emergency services (including ambulances and urgent care centers).

The FDA says “These defibrillation electrodes have been recalled because Philips made changes to the design of their connectors for the FR3 and FRx AEDs. Because of these changes, the Covidien defibrillation electrodes will not work with these AEDs.”  There have been recalls of other defibrillators with related components, including the Philips HeartStart. See the Harman Law page Trilogy Ventilator Failure for more information.

If you or someone you know has experienced serious injury or death as a result of the use of a defibrillator, there may have been a Covidien electrode involved. Call Harman Law immediately at 1-888-55-HARMAN for a no cost, no obligation consult. The attorneys work closely with physicians to find out if a specific medical device was the reason for injury or death.

  • Harman Law LLC represents clients across the country who have been injured by dangerous and defective consumer medical products and devices.

Links

FDA Recall Notice: Covidien, Medi-Trace Cadence and Kendall Defibrillation Electrodes – Electrodes will Not Work with Philips FR3 and FRx Automated External Defibrillators (AEDs), September 18, 2014

FDA Recall Notice: Philips HeartStart FRx, HeartStart HS1 Home and Heartstart HS1 OnSite Automated External Defibrillators, December 3, 2013