Dive Brief:

• FDA has issued another Class I recall notice about Medtronic’s HeartWare HVAD ventricular assist device, noting the product "may cause serious patient harm including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures and death.​"

• The safety alert, posted on Thursday, describes issues that can cause the outflow graft to tear and the strain relief screw to break before the heart pump is implanted. Medtronic had heard of four deaths linked to the outflow graft problem as of March 5.

• FDA issued Thursday's recall notice a little more than two months after it posted a Class I alert about another HeartWare HVAD issue implicated in the death of a patient.

Dive Insight:

Physicians use Medtronic’s implantable HeartWare device and linked external controller to help keep blood pumping in patients with end-stage heart failure. However, the device has been the subject of more than a dozen Class I recall notices, the most serious type issued by FDA, since 2014, according to the agency's medical device recalls database.

Medtronic alerted users to the latest problem last month. In the notice, Medtronic outlined the risks of tears and breakages during assembly. FDA reiterated the problem in its Class I recall notice.

Some patients have suffered those adverse events. As of March 5, Medtronic had received 92 complaints related to the assembly of the nearly 22,000 HeartWare HVAD pumps it had distributed as of that date. Healthcare professionals typically identified the problem before or during surgery.

The most common and serious problem was related to outflow graft tears. Among the 54 complaints sent to Medtronic about graft tears were two deaths related directly to the problem and two linked to later complications after outflow graft intervention. Around half of the complaints detailed critical patient harm. Graft tears put patients at risk of bleeding during and after the procedure.

The remaining 38 complaints detailed strain relief screw breakages. As of March 5, Medtronic was yet to learn of harm to patients linked to screw breakages.

Rather than pull the affected products from the market, Medtronic advised users to follow additional steps in its instructions for use. The revised document asks users to take actions to prevent bunching, damage and tears to the outflow graft, as well as avoid using excessive force when tightening the outflow graft strain relief screw due to the risk of breakages. 

FDA’s recall notice covers almost 5,000 devices distributed in the U.S. between March 2018 and April 2020. The notice asks users to follow the additional instructions for use shared by Medtronic. FDA is working with the company on a design change to lower the risk of tears and breakages.