FDA Recalls Abbott Heart Pumps Over Concerns of Fatal Blockages

• FDA announces recall of Abbott's HeartMate II and HeartMate 3 heart pumps due to risk of injury and death from biological material buildup that can block blood flow.

• Recall comes years after some surgeons first noticed problems; raises questions about reporting of issues with approved devices.

• Devices help pump blood for patients with end-stage heart failure waiting for transplant or as permanent solution.

• Abbott says rates of complication are low, but FDA database shows 130 related reports, earliest from 2020.

• If devices removed from market, could leave some end-stage heart failure patients with no options.