Posts Tagged 'heart pump'

FDA Warns on Leadless Heart Pacing Systems

new Medtronic pacemaker seeing issues even before releaseAfter observing what it calls “major complications related to cardiac perforation” in patients undergoing pre-market trials for Medtronic’s Micra leadless pacemaker, the FDA has reiterated its warnings to cardiac care providers over the use of leadless devices.

Pacemakers generally come in one of two varieties: either leadless or transvenous. While transvenous pacemakers have been in use for quite some time, the transition to leadless devices has ...

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Medtronic Heart Pump Recalled Over Potentially Fatal Flaw

medtronic heartware hvad system under recallLast year, medical devices manufacturer Medtronic bought HeartWare, the company behind a heart pump known as the HVAD system. The deal cost Medtronic $1 billion.

Prior to the purchase, HeartWare had received not one, but two safety letters from the U.S. Food and Drug Administration over issues related to the HVAD pump. These letters detailed agency concerns over the effects of moisture on the HVAD system. Medtronic ...

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