A Medical Device Daily
Laerdal Medical Corp. (Wappingers Falls, New York) said last week that it has initiated a voluntary recall of all lots of its CM 100-Heartstart Adapter Cable, used with certain defibrillators, after receiving reports regarding instances of wire breakage in the cable that prevented delivery of defibrillation shocks.
Noting that the test method described in the defibrillator instructions for use “will not detect internal breaks in the adapter cables,” Laerdal said use of the adapter cables in question should be discontinued.
The CM 100-Heartstart Adapter Cable allows Laerdal Heartstart brand defibrillation electrodes with snap connector to be used with HP/Agilent/Philips CodeMaster 100 and CodeMaster SL+/XL/XE defibrillators, Laerdal Heartstart 4000 defibrillators and Philips HeartStart XLT, HeartStartXL and HeartStart MRx defibrillators.
Laerdal said the adapter cable was supplied as a standard accessory with most CodeMaster 100 defibrillators that it distributed and was sold as an optional accessory for use with the Laerdal Heartstart 4000 AED.
The company said more than 3,000 of the 26-inch long, Y-configuration cables have been sold in the U.S. since 1996. The cable assembly features one cylindrical white two-pole connector at its base and a patient electrode snap connector on each of the two remaining leads.
Laerdal said it does not offer replacement cables, but that alternative compatible cabled electrodes that do not require adapters are available from Philips Medical Systems.
The company said the recall is being conducted with the knowledge of the FDA.
Laerdal Medical Corp. is a subsidiary of Laerdal Medical AS (Stavanger, Norway).