Thoratec’s (NSDQ:THOR) voluntary "correction" for the HeartMate II heart pump was slapped with Class I recall status from the FDA on concerns that an improperly connected component may result in deformation or tearing of the device’s outflow conduit.
The Pleasanton, Calif.-based device maker issued a correction notice in February warning physicians that a small portion of the HeartMate II devices’ sealed outflow graft bend reliefs, designed to prevent a connector between the pump and the aorta from kinking, were not properly connected.
The issue was reported in less than 1% of 3,200 devices and most cases were discovered in X-ray images or during surgical procedures. It may have been a contributor to at least 1 patient’s need for replacement surgery.
Detached bend reliefs can cause low or fluctuating pump flow, hemolysis, varying speed and/or power or worsening symptoms of heart failure, and "may cause serious adverse health consequences, including death," according to the FDA.
"The firm states that the device labeling has been revised to provide instructions on how to verify the bend relief is fully engaged with the sealed outflow graft at the time of implant and new caution statement regarding the bend relief connection are included," according to the FDA warning. "Clinicians have been instructed to follow the revised instructions for use that clarify the recommended procedure for securing the bend relief to the outflow graft."
Thoratec contacted all the hospitals it had sold the HeartMate II device to following the February notice in order to provide new information and clarify proper implant procedure, according to a press release. No devices were returned, and the company doesn’t expect any material impact from the measure.
THOR shares were down 0.2% to $32.75 as of about 11:10 a.m. today.
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