FDA Recalls HeartMate device Manufactured by Abbott

June 7, 2018  Source: Ddu 229

On Tuesday, the FDA issued a recall on pharma giant Abbott’s HeartMate 3 Left Ventricular Assist Device.

This will be the second recall on a heart device this month Medtronic’s Heartware device and accessories was recalled a few days ago. This comes after Abbott issued a patch to negate cybersecurity issues 350,000 remote monitoring systems and pacemakers. 

The FDA tagged Abbott’s HeartMate medical device a Class 1 recall (the most urgent category), as it can cause low blood flow and blood clots, and could possibly lead to major injury or death.

In their latest statement, Abbott officials said that worldwide there have been 32 reports of device malfunctions.  The issues may be caused by interruptions in electrical connections between power sources, adapters, including batteries, and the HVAD controller, which could cause a problem in the connection leading to the possible halting of the pump.

Abbott also said in a statement that nearly 5000 units which were manufactured since 2014 have been recalled. No devices are being removed from patients or hospitals.

The HeartMate is used in the patient with acute left ventricular heart failure and assists by pumping blood. It is more commonly implanted while a patient waits for heart surgery. On April 5, Abbott informed doctors and global regulatory agencies about the device malfunction. The FDA asked patients with the HeartMate to have an echocardiogram to check the device.

By Ddu