Recall of LVAD implant kit designated class I; two deaths reported
Key takeaways:
- The FDA designated Abbott/Thoratec Corp.’s recall of it’s LVAD implant kit as class I.
- Blood leakage or air entering the seal between the inflow cannula and apical cuff may result in injury or death.
Abbott/Thoratec Corp. announced the recall of its left ventricular assist device implant kit due to complaints of blood leakage or air entering the seal interface between the LVAD inflow cannula and the apical cuff.
The FDA has identified the recall of the LVAD implant kit (HeartMate 3) as a class I recall, the most serious type of recall, as use of the devices may cause serious injury or death. The FDA stated this recall is a correction, not a product removal.
Blood leakage or air entering the seal interface between the LVAD inflow cannula and the apical cuff could impair integrity of blood flow, leading to longer than expected surgery, hemorrhage, right HF or air embolism, according to an alert from the FDA.
There have been 70 injuries and two deaths related to the issue and, in all reported events, the issue was observed during device implantation.
The recall includes 882 devices distributed from March 1, 2021, to present.