Thursday, April 05, 2012

FDA recalls LV assist system

The "recall" is a notice that the label on the product has been revised to bring greater attention to the problem and clarity about its solution.

"Instructions on how to verify [that] the bend relief is fully engaged with the sealed outflow graft at the time of implant and [a] new caution statement regarding the bend relief connection are included" in the revised labeling, according to a statement issued by the company.
Several problems could arise if the bend relief detaches from the device and the tubing kinks or deforms, including:
  • A reduction of blood flow from the device
  • Graft thrombosis
  • Perforation of the outflow graft
The affected models are 103393, 103695, 104692, 104911, and 104912.