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Recall of Certain Thoratec VADs
Posted on April 29, 2008
Thoratec, a manufacturer of medical devices, is conducting two recalls related to its TLC-II ventricular assist device (VAD) systems.
One recall applies to TLC-II paracorporeal VADs manufactured between January 1, 2004 and October 2, 2006. The problem is with the collet nuts that connect the VAD to the inflow cannula. When these components were redesigned, the newer inflow cannula had a smaller diameter. If the newer cannula is used with the older design of collet nut, the cannula can disconnect from the pump and result in severe patient bleeding.
The older collet nuts for the inflow cannula are black in color, whereas the newer ones are white. The company says that black collet nuts should not be used with any VAD. Hospitals should make sure that all patients are using the redesigned white collet nut that is packaged with the redesigned inflow cannula.
The other recall affects the portable driver that can be used with the TLC-II VADs. This driver is a mobile unit that powers the blood pump when a patient is ambulatory and it can be used with either the paracorporeal or implantable VAD. The problem is that the driver's compressor motor may wear out much earlier than the expected 3000 hours of use. If that happens, the driver could stop working without warning, which would stop the patient's circulatory support.
This recall includes all drivers manufactured since September 2005. The company says that hospitals should check their current inventory and not use drivers with more than 1500 hours of use until they have been serviced. Hospitals should contact Thoratec to arrange for servicing.
Patients on VAD support with a TLC-II portable driver should immediately contact their hospitals to determine if their device is affected by this recall. Patients should also have a back-up driver and hand-pumps available at all times, and they or their caregivers should be trained in back-up procedures.
Additional Information:
FDA MedWatch Safety Alert. Thoratec Paracorporeal Ventricular Assist System (PVAD). July 27, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#PVAD
FDA MedWatch Safety Alert. Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver. July 27, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#TLCII
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