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FDA Issues Class 1 Recall for Covidien Defibrillation Electrodes

The FDA has issued a Class 1 Recall for certain Medi-Trace™ Cadence and Kendall™ Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillators. The FDA defines a Class 1 Recall as the “most serious recall where there is a reasonable risk of a serious adverse health consequence or death.”

Covidien alerted customers to this issue on September 18, and has since revised labeling to clarify that the use of these electrodes is incompatible with Philips FR3 and FRx AED units. On October 10, 2014, Covidien announced that it has notified customers of a voluntary Field Safety Alert for these certain Medi-Trace™ Cadence and Kendall™ Multi-function Defibrillation Electrodes, warning that these electrodes could result in a delay of therapy. Covidien announced that this safety alert affects a total of 644,460 electrodes and two reports have been received “where customers attempted to use a Covidien electrode with a Philips FR3 AED unit. The mismatch of these devices contributed to a delay in resuscitation and may have contributed to the subsequent death of one patient.”

The recall includes the following types of Covidien electrodes:

  • 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

 

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