FDA announces class 1 recalls for heart devices, ventilators

Editor's Note

The US Food and Drug Administration (FDA) has classified recalls of Abbot’s HeartMate 3 Left Ventricular Assist System (LVAS) implant kits and Phillips Respironics' Trilogy Evo ventilators as class 1, the most serious category indicating risk of serious injury or death.

Used while waiting for recovery, a transplant, or as a permanent solution when a transplant is not an option, the LVAS kits help the heart pump blood in patients with severe left ventricular heart failure.

The May 15 recall announcement cites complaints about blood leakage or air entering the seal interface between the left ventricular assist device (LVAD) inflow cannula and the apical cuff. In all reported events, the issue was observed during implantation of the device. Blood leakage or air entering the LVAD from this location will impact the integrity of the blood flow and may lead to longer than expected surgery, bleeding (hemorrhage), right heart failure, or air embolism. Abbott reports 81 incidents, including 70 injuries and two deaths related to this issue. 

In a March 20 Urgent Medical Device Correction Notification letter, the company advised customers against returning unused products, and to follow standard surgical processes and existing instructions for use (IFU) in the event of blood leak or air entrapment. Customers must ensure residual air is completely evacuated from the blood chamber before initiating LVAD support; ensure proper management of homeostasis before closing wounds; always have a back-up system; and use conventional strategies to resolve air leaks or surgical bleeding (such as adjusting pump position).

Phillips Respironics’ Trilogy EVO, EV300, Evo 02, and Evo Universal use microprocessor-controlled blowers to provide pressure support, pressure control, or volume control during breathing support. Due to a software issue, ventilators can issue a “Battery Depleted” or “Loss of Power” alarm while sufficient power is still available, resulting in a sudden loss of ventilation and serious harm—including death—while the device alarms. To resolve the issue, customers should update to the latest software version (1.05.06.00).

As of FDA's May 13 recall announcement, there are no reports of death or serious injury related to this issue.