October 14, 2014 — Covidien is recalling Medi-Trace™ Cadence and Kendall™ Multi-function Defibrillation Electrodes because they may not work with Philips FR3 and FRx defibrillators.
The FRx AED unit requires the pads to be pre-connected. If they are not connected, it will issue a continuous chirping alarm to alert the user of the problem. The FR3, however, does not require pre-connection and it does not issue an alarm. Users may not discover the issue until the AED fails to deliver a shock in a life-threatening medical emergency.
The compatibility issue could result in a delay in therapy, which may have contributed to the death of a patient:
“Covidien has received two reports 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 affects nearly 645,000 electrodes. Some were sold by Covidien under private-label agreements with MediChoice and Philips HeartStart AEDs.
This is not the first recall affecting the Philips HeartStart. Last year, the FDA issued a Safety Communication and warned that the HeartStart FRx may have a defective electrical component that could cause it to fail to deliver a shock.
Recalled products 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
- MC1710H – MediChoice® Multifunction Electrode
- M3718A – Philips HEARTSTART Multifunction Electrode Pads
Do I have an AED Injury Lawsuit?
The Schmidt Firm, PLLC is currently accepting defective defibrillator induced injury cases in all 50 states. If you or somebody you know has been injured by a defective device, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.
The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.
