Two implanted ... devices not being removed from the market. "The HeartMate II and 3 are used for both short- and long-term support in adult patients with severe left ventricular heart failure ...
Two implanted devices used to keep blood flowing in people with end-stage heart failure are now under recall The FDA says obstructions can form over time in the HeartMate II and HeartMate 3 ...
Two implanted ... FDA explained in a statement. "It can be used while waiting for a heart transplant, to help the heart recover, or as a permanent solution when a transplant isn't an option." The ...
In the latest notice, which follows a February recall of the device for a separate issue, Abbott took action due to reports of blood leakage and air entrapment.
Initiated by Abbott/Thoratec and deemed Class I by the FDA, the recall is in response to reports of 70 injuries and two ...
Getinge has initiated 20 recalls related to problems with balloon pumps and cardiopulmonary bypass devices in less than 16 months, according to the notice. The FDA is concerned Getinge has yet to ...
May 8 (Reuters) - The U.S Food and Drug Administration (FDA ... opens new tab heart devices in patients as they faced safety and quality concerns despite a string of recalls.
In a statement Wednesday, the FDA said it recommended providers find alternatives to Getinge's balloon pump and bypass devices ... to the heart's left ventricle. Eight of the recalls fall within ...
May 8 (Reuters) - The U.S Food and Drug Administration (FDA ... using Getinge's heart devices in patients as they faced safety and quality concerns despite a string of recalls.
Getinge has initiated 20 recalls related to problems with balloon pumps and cardiopulmonary bypass devices ... and heart pumps and initiated U.S. recalls of both groups of products. The FDA ...
The device monitors Tanner’s heart ... from the FDA and the National Library of Medicine saying some implanted defibrillators were vulnerable to hackers who could hijack the devices and could ...