Medtronic Inc on Friday said it was recalling two older models of certain heart devices after the company became aware of four deaths and one serious injury that could be related to the failure of a key part of one of them.
Medtronic shares fell 6 percent in after-hours trading following the announcement of the Class 1 recall, which the US Food and Drug Administration defines as a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.
The company said most of the recalled implantable cardioverter defibrillators (ICDs), which are used to shock the heart back into normal rhythm, were implanted in 1997 and 1998 and are close to the normal replacement time.
The devices in question may take a longer than normal time to charge before delivering the life-saving jolt due to a possible problem with the capacitors, Medtronic said.
The Minneapolis-based company no longer uses the capacitor technology in its newer ICDs.
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