FDA hands Class I label to Abbott HeartMate LVAD software recall

FDA hands Class I label to Abbott HeartMate LVAD software recall

An Abbott recall concerns more than 1,500 of the tablet apps used to communicate with and control its implanted long-term heart pumps, after reports that software issues could cause the pumps to stop or start unexpectedly.

This week the FDA elevated the product correction to a Class I recall, its most serious designation. Abbott first notified its HeartMate 3 LVAD users and healthcare providers of the issue with a letter (PDF) in early January, saying that it received reports of eight patient injuries over the previous three years and no deaths.

The recall specifically concerns the HeartMate Touch Communication System, which includes a tablet, wireless adapter, flash drive and USB cable to connect with the left-ventricular assist device’s controller. The system is only used by clinicians in hospitals or clinics, such as during implant and removal procedures or for more-detailed patient monitoring, according to the FDA.

The issue can occur when the tablet is disconnected from the implant before it has completed sending and confirming a command to stop the pump. This could cause that command to be saved in a queue, and inadvertently delivered when it is reconnected to a subsequent implant controller—causing a previously stopped pump to start, or a running pump to stop, leading to sudden and potentially dangerous changes in blood flow.

The HeartMate 3 LVAD is designed for patients with end-stage heart failure. Powered by external battery packs, the implant takes blood from the ventricle and pumps it into the aorta, with the goal of keeping the patient alive until they can receive a transplant. Abbott said it is developing a software update to correct the issue and plans to roll out the upgrades in the second quarter of this year.

Abbott also sent an advisory letter (PDF) in February regarding the HeartMate 3 system, as well as its predecessor model, informing providers of its plans to update its instructions for use regarding the potential for clogs within the implant’s tubing with long-term use.

Biological material can collect within the pump’s outflow graft components over a period of years, the company said, resulting in obstructions and persistent “low flow” alarms. In its letter, Abbott provided information on how to recognize and diagnose the condition; no devices or equipment needs to be returned to the manufacturer.

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