CONMED Recalling Electrode Pads Used with Philips AEDs

Utica, N.Y.-based CONMED is recalling its Adult Radiotransparent, Pediatric Radiotranslucent, Mini Pediatric Radiotranslucent, Pediatric R2 Multifunction and R2 Multifunction Electrodes due to design changes Philips made to its FR3 and FRx automatic external defibrillators that render the electrodes useless.

CONMED issued the Class I recall because the patients won’t know the electrode pads don’t work until they attempt to use the defibrillator. This can result in a delay in delivering electrical therapy to revive a patient, potentially causing serious injury or death, the recall notice says. It was posted to the FDA’s website Wednesday.

The company sent an Urgent Device Correction letter to customers on Nov. 6, asking them to stop using the electrodes with the FR3 and FRx defibrillators. Distributors are asked to notify their customers, but do not need to return the products. The recall notice further instructs customers to only use the FR3 and FRx with Philips brand electrodes listed in the device manual.

The recall includes all units distributed between March 1, 2012, and Oct. 29, 2014. CONMED emphasizes that its electrodes will still work with other Philips automatic external defibrillators that accept plug style connectors.

View the recall notice at www.fdanews.com/12-08-14-CONMED.pdf. — Kellen Owings

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