Philips HEARTSTART Electrode Pads Recalled for Incompatibility with AEDs
Covidien is recalling Philips HEARTSTART Multifunction Electrode Pads because they are not compatible with Philips FR3 or FRx AEDs.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device (AED electrodes) where incompatibility poses a risk of harm (failure to defibrillate) in an emergency, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Covidien LLC is recalling 151,210 pairs of Philips HEARTSTART Multifunction Electrode Pads, Part Number M3718A. The recall is due to the electrodes not being compatible for use with Philips model FR3 or FRx Automated External Defibrillators (AEDs).
The affected products were distributed worldwide, including the United States (nationwide), Puerto Rico, Canada, Greece, Israel, Belgium, Finland, France, Germany, Great Britain, Ireland, Italy, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Brazil, Chile, Philippines, Taiwan, Australia, and New Zealand. All lot codes are affected.
Users should stop using these electrode pads with Philips FR3 or FRx AEDs and contact the manufacturer for instructions on replacement or return.
The recalled product
- Product
- Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
- Manufacturer
- Covidien LLC
- Affected units
- 151,210
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)
- Al lot codes
Distribution
Part of a larger recall action
This product is one of 6 recalled by Covidien LLC 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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