A ventricular assist device is a mechanical pump that helps a person’s heart that is too weak to pump blood through the body.
The Thoratec Corporation of Pleasanton, California has announced Class 1 Recalls of two medical devices today in cooperation with the FDA:
Thoratec Paracorporeal Ventricular Assist System (PVAD)
This P-VAD was recalled because it may contain a black collet (circular rim) that holds a rod-like nut in place, which was intended to be used with a cannula (a small tube) of an older design that had a larger diameter. If this black collet and nut is used with the current design of cannula that has a smaller diameter, it can disconnect during use.
The VAD is designed to provide sufficient blood flow to the damaged or diseased heart, and if it is not working properly the patient could suffer further injury to the heart, or possibly die from lack of blood flow. Thus, it is very important that medical professionals check their PVADs from Thoratec to determine which design is being used. They are advised to dispose of any expired original design cannula. Do not use the black collet and nut with any design VAD. Make sure that all current patients using PVADs are using the white collet nut that is packaged with the cannula. Patients may call Thoratec Corporation at 1-925-847-8600.
Because Thoratec has already alerted hospitals and medical center customers of this ‘urgent recall’, it is up to the individual doctors to contact their patients.
Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver
Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver, Catalog No. 20010-0000-032 has been recalled because the VAD support for the VAD driver may stop due to earlier than expected wear-out of the compressor motor (much less than the expected 3000 hours), causing inadequate blood flow to and from the heart.
The compressor motor can stop without warning! Medical professionals and patients are advised to check the current number of service hours on all units. Do not use the TLC-II drivers exceeding 1500 hours until they are serviced by Thoratec. Ensure that all patients have a back-up driver and hand pumps at all times and have been trained in backup procedures. When the 1500 hour limit has been reached, patients must stop using the device and send it to the manufacturer for servicing. Patients should replace all drivers at 1500 hours and go back to the hospital for a new backup replacement. Patients may call the company at 1-925-847-8600.