LeMaitre graft recall gets FDA's highest warning

July 24, 2013 by Arezu Sarvestani

The FDA puts its highest-risk label on a recall of LeMaitre Vascular's Albograft vascular graft.

LeMaitre graft recall gets FDA's highest warning

The FDA put its highest-risk Class I label on a recall issued by LeMaitre Vascular (NSDQ:LMAT) over leakage concerns for the Albograft vascular grafts.

The affected devices, manufactured in April 2011 and distributed through June 2013, were only distributed in Pennsylvania, according to the FDA notice.

"This product was recalled due to blood leaking from the surface of the graft after implantation," the FDA reported. "This product may cause serious adverse health consequences, including death."

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The federal watchdog agency further noted that LeMaitre Vascular personally visited its affected customer on June 18, removing the recalled devices from the shelves. LeMaitre issued an "urgent field safety notice" a day later informing customers to remove the Albograft devices and return them to the company for replacement.

Albograft is a synthetic graft used to repair arteries that may be damaged due to aneurysm or blockage.