Agency classClass IOur severity:Critical FDA (Devices)·Z-0454-2015·Announced 2014-12-10

ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Failure

ConMed is recalling Adult Radiotransparent Electrodes because a design change in Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states that the failure to connect may result in patient death or serious injury, which meets the rubric criteria for a Critical severity score.

Plain-English summary

ConMed Corporation is recalling 174,610 units of Adult Radiotransparent Electrodes (REF/Catalog Number 2001H). These single-use, disposable devices are intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. The recall covers units distributed nationwide in the United States, Puerto Rico, and internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.

The recall was initiated because Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. This design change may result in a failure to connect the electrodes to the devices. A failure to connect may result in a delay of therapy, which could result in patient death or serious injury.

Healthcare facilities and consumers should stop using these electrodes immediately. ConMed Corporation is the recalling firm responsible for managing the recall.

The recalled product

Product: ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use…
Manufacturer: ConMed Corporation
Category: Medical Device — Electrodes
Hazard: delayed-therapy
death
serious-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All Lot Codes

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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Same hazard · delayed therapy