Medtronic HVAD Recall Given High-Risk Class I Designation
A welding defect may allow moisture to enter affected heart pumps, which can lead to device failure, the US FDA explained. Medtronic first announced the recall in April.
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In a near-repeat of a May recall, the US FDA has labelled Medtronic’s recall of its HeartWare Ventricular Assist Device System class I because of another issue with the system’s batteries.
The US FDA has identified a recall of Covidien catheters due to a hub defect as class I. The agency’s most serious designation is yet another for the company, which has recently recalled several devices.
For Second Time This Month, Medtronic Announces Class I FDA Recall Related To HeartWare System Component
Medtronic, Baxter and BD are all facing recalls, with Medtronic finding yet another issue with HeartWare HVAD systems. Separately, the FDA put a Baxter respiratory device recall into Class I, and BD announced a recall on intraosseous devices.