ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Changes
ConMed is recalling 174,610 Adult 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 criteria for a Critical severity score.
Plain-English summary
ConMed Corporation is recalling 174,610 units of Adult Radiotransparent Electrodes (REF/Catalog Number 2001H-PC). The recall affects all lot codes and includes 168,090 units distributed in the US and 6,520 units distributed outside the US.
The recall is due to design changes made by Philips Healthcare to the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. These changes may result in a failure to connect, which could delay therapy and potentially lead to patient death or serious injury.
The affected products were distributed worldwide, including nationwide in the US, Puerto Rico, and internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain. Users should stop using these electrodes and contact ConMed Corporation for further instructions.
The recalled product
- Product
- ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
- 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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