Agency classClass IOur severity:Critical FDA (Devices)·Z-0461-2015·Announced 2014-12-10

ConMed Pediatric Multifunction Electrodes Recalled for Connection Design Flaws

ConMed is recalling Pediatric R2 Multifunction Electrodes because design changes to the connection with Philips Heartstart devices may cause connection failures, potentially delaying therapy and leading to 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 criteria for a Critical severity score (5) under the rubric.

Plain-English summary

ConMed Corporation is recalling CONMED PEDIATRIC R2 Multifunction Electrodes (REF/Catalog Number 3115-1750). These single-use, disposable devices are intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications and are designed to connect directly to Philips Heartstart devices. The recall covers 174,610 units, including 168,090 in the United States and 6,520 outside the US.

The recall was initiated because Philips Healthcare made changes to the design of the connection between the 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.

The affected products were distributed worldwide, including 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. All lot codes are affected. Healthcare facilities and users should stop using these electrodes and contact ConMed Corporation for further instructions.

The recalled product

Product: CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -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: connection-failure
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 · connection failure