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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In a narrative that has become all too familiar when referring to one of the most openly corrupt institutions in the American government, reports have surfaced that the FDA knowingly allowed a faulty medical device to make its way into unwitting patients. This time the device in question is quite literally responsible for keeping patients’ blood circulating through their bodies.
The HeartWare Ventricular Assist Device, or HVAD ...
continue reading...A recall has been issued for the Medtronic Rashkind balloon septostomy catheter. 142 of the devices are covered under the federal recall action and were distributed throughout the United States between May 2018 and August 2020.
According to the FDA, the recall was issued because “quality issues…may lead to the device breaking, separating or failing during use.” The agency goes on to say that “if this occurs, ...
continue reading...When news broke of an internal FDA database of medical device injuries so secret that few within the agency even knew of its existence, the discovery obviously led to the raising of a multitude of questions. Why was an agency tasked with keeping American families safe allowing the companies it was supposed to be regulating to hide reports of injuries caused by their devices? Why ...
Last 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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Ireland-based medical device company Medtronic has issued a worldwide recall of certain lots of its Covidien Shiley neonatal and pediatric tracheostomy tubes. According to the U.S. Food and Drug Administration (FDA), Medtronic announced on May 8 that it had begun “notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley(TM) tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, ...
