After 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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Nearly seven years’ worth of pacemakers manufactured by Boston Scientific have been recalled over concerns that they can fail to a backup mode and no longer properly pace the patient’s heart. The recall affects 48,000 Ingenio pacemakers manufactured between September 2011 and December 2018. The units continued to be distributed to medical providers through August 1, 2020.
According to the Boston Business Journal, safety mode was created as a ...
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Shortly after warning patients that their implanted heart defibrillators were having battery problems and may not work when needed, St. Jude Medical Inc. (no relation to the St. Jude Children’s Research Hospital) has advised doctors to stop implanting their devices for a separate and unrelated reason.
Concerns over St. Jude defibrillators initially focused on the units’ batteries depleting faster than they should. This would result in a ...
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