FDA recalls 5,000 Abbott heart devices worldwide

HeartMate3 recalled because of unintended disconnection between power source and controller.
By Bernie Monegain
12:10 PM
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The U.S. Food and Drug Administration FDA on Tuesday issued a recall of a medical device, the HeartMate 3 Left Ventricular Assist Device, manufactured by pharmaceutical giant Abbott and in use at healthcare organizations around the world. 

Abbott’s is the second heart device recalled in a month’s timespan. The other was Medtronic’s Heartware device and accessories. Also, Abbott in mid-April issued a patch to fix cybersecurity issues in some 350,000 of its pacemakers and remote monitoring systems.  

Now, the FDA said the issues with Abbott’s HeartMate device could lead to low blood flow or clotting and tagged the recall a Class 1 – the most urgent category, which indicates the possibility of serious injury or death.

Abbott officials said in a statement that there have been 32 reports of device malfunctions worldwide. The failures may stem from possible interruptions in the electrical connection between power sources, including batteries, adapters and the HVAD controller, which could cause disconnection and result in possible pump stoppage, according to Abbott executives.

The recall applies to devices made since 2014, or nearly 5,000 units worldwide. No devices are being removed from patients or hospitals, Abbott said in a statement.

The HeartMate helps damaged hearts pump blood more effectively, and is used for patients with severe left ventricular heart failure. Patients usually have the device implanted while waiting for a heart transplant.

[Also: HIMSS weighs in on FDA software pre-cert program]

Abbott notified physicians and global regulatory agencies about the device malfunction April 5, it said in a statement. The FDA recommended that patients with the HeartMate have an echocardiogram to check the device. Surgical repair might be needed, the agency said.

Medtronic, for its part, issued a recall on May 22 of 204,017 devices, including the HeartWare and accessories, manufactured and distributed between March 2006 and May 2018, according to an FDA notice.

Medtronic said the recall affects 16,399 implanted HeartWare HVAD devices as of May 22, and clarified that there have been no reports of serious harm related to the recall, calculating the per-patient probability of serious adverse events at approximately 0.003.

The recall affects HeartWare controllers and controller kits with model numbers 1400, 1401, 1403, 1407 and 1420, HeartWare DC adapters with model numbers 1435 and 1440, AC Adapters with model numbers 1425 and 1430 and battery packs with model numbers 1650.

Twitter: @Bernie_HITN
Email the writer: bernie.monegain@himssmedia.com