USFDA CDRH Medical Device Safety and Recalls: Covidien, Medi-Trace Cadence and Kendall Defibrillation Electrodes...

A recall has been issued for the Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes because the electrodes will not work with Philips FR3 and FRx Automated External Defibrillators.  
Philips made changes to the design of their connectors for the FR3 and FRx AEDs, and because of these changes, the Covidien defibrillation electrodes will not work with these AEDs.  Use of these electrodes could cause a delay in delivering electrical therapy that is needed to revive patients. Additionally, their use could lead to severe health problems such as stroke, organ failure, or death if alternative defibrillator electrodes are not readily available. Covidien received two reports of injuries. There was a delay in resuscitating one patient which may have contributed to the subsequent death of the patient.  

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