Posts Tagged 'rashkind catheter'

Medtronic’s Diabetes Unit Gets a Warning Letter from the FDA

Medtronic finds itself on regulatory radar againMedtronic has recently notified the public that it received a warning letter from the FDA over quality control concerns at its diabetes unit. Included within that letter were issues related to the corporation’s risk assessment, its propensity for device recalls, and the way it handles complaints that are brought to its attention. News of the letter sent Medtronic’s stock price down to some of its lowest points ...

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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 caused ...

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Medtronic Heart Catheter Recalled After Injuries, Deaths

recall issued for Medtronic heart cathetersA 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, use ...

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