Covidien is alerting customers of an incompatibility issue with defibrillation electrodes, which the FDA has classified as a Class 1 recall.

The voluntary safety alert covers some Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes, which will not connect with Philips FR3 or FRx automated external defibrillators (AEDs). The company warned that only Philips brand electrodes should be used with these AED devices.  

Covidien received two reports of the mismatch, which led to a delay in resuscitation. One patient later died. Covidien revised labeling to clarify that the defibrillation electrodes are not compatible with Philips FR3 or FRx products.

Affected electrodes include:

• 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

These private label electrodes also have a connector compatibility issue:

• MC1710H - MediChoice Multifunction Electrode
• M3718A – Philips HEARTSTART Multifunction Electrode Pads

The FDA instructed healthcare professionals and customers to report any adverse events or quality problems related to these defibrillation electrodes to its MedWatch program.