heart device

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 [...]

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, [...]

  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 [...]

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 [...]

  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 [...]

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 [...]

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; [...]

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 [...]

  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 [...]

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 [...]