FDA has categorized the action as a Class I Medical Device Recall, after dozens of reports involving problems with Abbott cardiac catheters leaking air inside a patient’s bloodstream, resulting in a risk of serious injury or death
Abbott Trifecta valve problems have been linked nearly 200 patient deaths since 2011, data suggests.
This is the latest in a long history of Medtronic HVAD system recalls linked to the defective design and manufacturing of the heart implants.
Problems with Medtronic Cobalt/Chrome ICDs and CRT-Ds could result in reduced shock therapy, which may fail to correct heart rhythms.
While no details of the Medtronic pacemaker settlement have been released, the agreement comes only a few months after a judge rejected an attempt by the heart implant manufacturer to dismiss the lawsuit
