Abbott (NYSE:ABT) last Friday warned about possible issues with its HeartMate 3 left ventricular assist device over possible twisting of the outflow graft that can occur post-implant and could result in a persistent low-flow alarm, which normally signals potential safety risks including low blood flow or clotting.
The Abbott Park, Ill.-based company is not recalling any such devices from patients or hospitals, but said it has received 32 reports of such twisting amongst the 4,467 HeartMate 3 devices implanted worldwide.
Reports include issues related to low blood flow, clotting and three deaths that could be linked to outflow graft twisting, Abbott said.
The company reported that it has begun contacting physicians and patients implanted with the HeartMate 3 in the event that they receive reports of persistent low flow alarms that could indicate such twisting.
Abbott said it has also notified the appropriate regulatory bodies of the issue, as well as implanting physicians to try and monitor and prevent future issues related to twisting, according to a press release.
Abbott won FDA approval for the HeartMate 3 implantable heart pump last August, cleared for patients awaiting a transplant.
