Thoratec’s International Technidyne Corp. (ITC) division has received an FDA warning letter citing concerns about its quality systems, specifically those related to certain lots of its ProTime System anticoagulation monitoring device.
The company said the letter relates to manufacturing and quality control issues involving a component from an outside supplier that could cause specific lots of the system to deliver error messages on the display instead of test results or the “remote possibility” of incorrect readings of patient blood coagulation levels.
ITC is scheduled to meet with the FDA to discuss the warning letter and said part of its corrective action will likely involve a voluntary recall of certain lots of its ProTime system, approximately 5,800 devices. ITC said it is not aware of any patient-related issues related to the matter, adding that the issue has been addressed and should not affect any future shipments.
Thoratec also announced a worldwide recall, initiated Oct. 19, involving implantable ventricular assist devices (IVADs). The company has received seven reports of damaged drivelines in paracorporeal IVADs, five of which resulted in patient injuries and one in a patient death.