The U.S. Food and Drug Administration has issued a recall of Thoratec Corp’s HeartMate II pump after it was found that a critical part of the surgical procedure was left out of the instructions. This error could lead to serious side effects or even death.
The missing step might cause detachment of the bend relief from its intended position around the proximal outflow graft, which could allow the graft to kink of deform, resulting in reduction of blood flow from the pump, according to the Food and Drug Administration.
According to analysts, the recall does not mean the product must be removed from shelves or that Thoratec has to stop efforts to market the product.
The FDA recommended a device label revision providing instruction son how to verify the bend relief is fully engaged with the sealed outflow graft at the time of implant and a new caution statement regarding the bend relief connection.
For more safety information from the FDA, visit the U.S. Food and Drug Administration website.