(Reuters) - The Food and Drug Administration issued a recall Wednesday of Thoratec Corp's HeartMate II pump after it was found that a key part of the surgical procedure was omitted from the instructions, which could lead to serious side effects or even death.
Analysts said, however, that the recall does mean the product will have to be removed from the shelves and Thoratec does not have to halt marketing the product.
The announcement was posted by the FDA on its website.
The FDA described the action as a Class I recall, the most serious type, and said clinicians have been instructed to follow the revised instructions for use, which "clarify the recommended procedure for securing the bend relief to the outflow graft."
If the two parts of the device are not secured correctly, the FDA said, the product may cause serious health consequences, including death. A new caution statement regarding the connection is included in the new label.
Thoratec was not immediately available for comment.