A heart assistance device manufactured by Thoratec has been recalled because the device may function incorrectly. The defective medical device has been used at 87 hospitals in the United States and around the world since 2004. The device is surgically implanted in patients and it may become bent.
Thoratec notified the hospitals of potential problem in an Oct. 19 recall notification letter, asking them to evaluate the drive line adjacent to the pump housing to ensure that it is not subject to extreme flexing or bending at acute angles on all patients using the unit.
The announcement comes a day after Thoratec said it might recall approximately 5,800 anticoagulation monitors in response to a Food and Drug Administration warning letter expressing concern about the devices.
The monitor may also be recalled due to incorrect test results being relayed. The heart assistance device has been linked to five injuries and one death.