Agency classClass IOur severity:Critical FDA (Devices)·Z-0459-2015·Announced 2014-12-10

ConMed Pediatric Radiotransparent Electrode Recall Due to Connection Design Changes

ConMed is recalling 174,610 pediatric radiotransparent electrodes because design changes to Philips AED connections may cause therapy delays, 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 could result in patient death or serious injury, which meets the rubric criteria for a Critical (Score 5) severity rating.

Plain-English summary

ConMed Corporation is recalling 174,610 units of Pediatric Radiotransparent Electrodes, catalog number 2603H. The recall involves 168,090 units distributed in the United States and 6,520 units distributed outside the US. The affected products are comparable to Philips Medical HeartStart electrodes with plug-style connectors.

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. These design changes may result in a failure to connect, which could cause a delay in therapy. The source text states that such a delay could result in patient death or serious injury.

The affected units were distributed worldwide, including nationwide in the USA, Puerto Rico, and internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain. All lot codes are affected. Users should stop using the recalled electrodes and contact ConMed Corporation for further instructions.

The recalled product

Product: PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
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