FDA Issues Class 1 Recall of Defibrillation Electrodes
The Food and Drug Administration issued a Class 1 recall of CONMED Defibrillation Electrodes due to the risk of serious injury and death.
A Class 1 recall is the most serious level of recall, meaning there is a reasonable risk of serious, and potentially fatal, health consequences. Certain PadPro and RD Multi0function Defibrillation Electrodes have been recalled due to a connector compatibility issue with Phillips FR3 and FRx Defibrillator Units.
A total of 174,610 units have been affected by the voluntary device correction.
The CONMED corporation, the manufacturer of the recalled devices notified their consumers of the voluntary urgent device correction through a letter sent out on November 6th, 2014. CONMED will revise the labeling of the electrodes to clearly state they are incompatible with Philips FR3 and FRx AED units.
The FRx AED unit requires the pads to be pre-connected before use. If the pads are not connected, the device will “chirp” an alarm at the user to alert the user. However, the FR2 does not require pads to be connected to the unit before use. Therefore, the user will not be alerted to the incompatibility issue until the AED is used. This can result in delayed treatment.
The multi-function electrodes were distributed globally to medical facilities from March of 2012 to October of 2014.
The affected units of CONMED electrodes include:
- Catalog Number 2001H – Adult Radiotransparent Electrode
- Catalog Number 2001H-C – Adult Radiotransparent Electrode
- Catalog Number 2001H-PC – Adult Radiotransparent Electrode
- Catalog Number 2516H – Adult Radiotranslucent Electrode
- Catalog Number 2516H-PC – Adult Radiotransparent Electrode
- Catalog Number 2603H – Pediatric Radiotranslucent Electrode
- Catalog Number 2602H – Mini Pediatric Radiotranslucent Electrode
- Catalog Number 3115-1750 – Pediatric R2 Multifunction Electrode
- Catalog Number 3115-1751 – R2 Multifunction Electrode
If you or someone you love has suffered injuries due to a defective medical device, contact our office for a free, no-obligation consultation.