ConMed Adult Radiotransparent Electrode Recall Due to 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 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, catalog number 2516H. The recall affects 168,090 units in the United States and 6,520 units outside the US. The products were distributed 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.
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 the electrodes to the devices. A failure to connect may cause a delay in therapy, which could result in patient death or serious injury.
Healthcare providers and facilities should stop using the affected electrodes and contact ConMed Corporation for instructions on how to return or replace the products. The recall covers all lot codes for this specific catalog number.
The recalled product
- Product
- ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, 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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