Medtronic recalls some Lifepak heart devices

Medtronic Inc is recalling some of its Lifepak heart monitors and external defibrillators because the devices can unexpectedly turn on and off, the company and U.S. regulators said on Thursday.

The Food and Drug Administration, in a statement, said it considered the recall of Medtronic’s Lifepak 15 emergency heart devices the most serious possible—a Class I recall—because the defect is serious enough to cause harm or death.

Lifepak devices are used in emergency settings by hospitals, the military and others to help the heart beat normally and to monitor patients.

No patients have been harmed, Physio-Control said in a statement. The recall affects Lifepak 15 devices made before Dec. 16, 2009, it said.

Devices in question “were manufactured with an internal component that could cause an electrical short that leads to the device turning off/on by itself or a power loss,” the company said. “A loss of power could delay or prevent delivery of defibrillation therapy.”

In March, the company had told those who had bought the devices that it would voluntarily fix the problems, but the FDA decided on Thursday to formally classify the problems as a formal recall.

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WASHINGTON (Reuters)