Another Class I Recall For HeartWare's HVAD System
Executive Summary
Medtronic announced FDA's high-risk designation of recalls from its new subsidiary’s products on Sept. 30. HeartWare products have been subject to a total of nine class I recalls since 2013.
You may also be interested in...
Medtronic HVAD Class I Recalls Keep On Coming
With recent actions, the Medtronic HeartWare left-ventricular assist device system, acquired last year, has 11 class I recall actions to its name in the US.
FDA Updates Class I Recall Alert For SynCardia's Bridge-To-Transplant System
SynCardia Systems' Freedom Driver System was subject to a class I recall last year, and now US FDA has updated its concerns about a component of the firm's Temporary Total Artificial Heart based on post-approval study data, and is asking that malfunctioning drivers be returned to the manufacturer.
HeartWare VAD Battery Alert Tagged As Class I Recall
An FDA recall notice states that HeartWare, which is being acquired by Medtronic, has recalled almost 19,000 ventricular-assist device batteries due to a risk of losing charge prematurely.