Newly Approved Medtronic Heart Device Component Under Recall
Just weeks after receiving Food and Drug Administration (FDA) approval, Medtronic’s EnVeo R Loading System, used with the CoreValve Evolut R system for transcatheter aortic valve replacement (TAVR), has been recalled. Medtronic said it had received eight reports of the presence of particulates in the EnVeo R Loading System. The … [Read more...]
Medtronic Recalls Heart Device Loading System Due to Particulates
Medtronic Recall Its Heart Device. Reports are gathered about the presence of particulates in the EnVeo R Loading System. Medtronic has announced the voluntary recall of its EnVeo R Loading System, which is used with its CoreValve Evolut R system for transcatheter aortic valve replacement (TAVR). The manufacturer received eight … [Read more...]
Class I Recall Announced for TigerPaw II Heart Device
Class I Recall For TigerPaw II Heart Device. This week, the Food and Drug Administration (FDA) announced the recall of the TigerPaw System II by Maquet Medical Systems. The TigerPaw II is an implantable left atrial appendage (LAA) occlusion device intended for use during heart surgery. The TigerPaw is a surgical staple used to … [Read more...]
FDA Class I Recall for TigerPaw II Heart Device
On May 7, 2015, the U.S. Food and Drug Administration (FDA) announced the recall of the TigerPaw System II by Maquet Medical Systems. The TigerPaw II is an implantable left atrial appendage (LAA) occlusion device meant for use during heart surgery. The device is a surgical staple used to close tissue in the LAA. The TigerPaw system … [Read more...]
Stronger St. Jude Durata Warning
St. Jude Durata Stronger Warning From FDA.Food & Drug Administration threatened to either impose a fine or take other actions against St. Jude Medical for neglecting to respond to the federal regulator’s concerns about the heart device, said The New York Times. In 2011, St. Jude issued a Class I recall on its Riata and Riata … [Read more...]
FDA Slammed Over Heart Device Trials
Journals accused the FDA of releasing some devices to market based on inadequate test results that are “open to bias." The U.S. Food and Drug Administration (FDA) has been criticized by two prominent medical journals over how it approves cardiovascular medical devices, says the Wall Street Journal. The journals accused the FDA of … [Read more...]
Patient Sues Heart Surgeon for Unauthorized Implantation of Experimental Device
Heart Surgeon Unauthorized Implantation. The Associated Press (AP) is reporting on a prominent Chicago surgeon earning royalties on a new heart device he implanted in a 41-year-old woman without her consent; this, according to a lawsuit filed by patient Toni Vlahoulis. Dr. Patrick McCarthy claims he donates the royalties to … [Read more...]
Replacing Heart Device Found Risky
High rate of serious complications, including death. Surgery to replace potentially defective heart defibrillators carries an unexpectedly high rate of serious complications, including death, according to a study published today. The research in the Journal of the American Medical Assn. showed that one in 50 patients needed to … [Read more...]
Implanted Heart Device Can Malfunction
Implanted Heart Device Can Malfunction. Implantable defibrillators, which can deliver a life-saving shock to people with damaged hearts, have had a roller-coaster record of reliability, as the rate of malfunctions fell in the early years, rose in the late 1990s and recently declined again. Compared with pacemakers, which are … [Read more...]
Risk cited in replacing heart device
Replacing the device might be riskier than leaving it in. A new study suggests that for some patients with implanted heart defibrillators that have been recalled by the manufacturer, replacing the device might be riskier than leaving it in. Canadian researchers found a much higher than expected rate of surgical complications in … [Read more...]
