ConMed Multifunction Electrodes Recalled for Connection Design Failure
ConMed is recalling multifunction electrodes due to a design change that may prevent connection to Philips AEDs, potentially delaying therapy.
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 severity score.
Plain-English summary
ConMed Corporation is recalling CONMED ADULT R2 Multifunction Electrodes (REF/Catalog Number 3115-1751) intended for use during defibrillation, cardioversion, pacing, and ECG monitoring. The recall involves 174,610 units distributed worldwide, including the United States, Puerto Rico, and various international locations.
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 users should stop using the affected electrodes and contact ConMed Corporation for instructions on return or replacement. The affected product is a single-use, disposable device assembled in Mexico.
The recalled product
- Product
- CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, 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, disposable…
- Manufacturer
- ConMed Corporation
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
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.
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