US device regulatory agency the FDA has issued a Class I recall, it’s highest category recall, for the LeMaitre Vascular Albograft Vascular graft, for the reason that it may leak from its surface following implantation. The same product was the subject of recall activity in Europe in March 2012, due to reports of profuse bleeding through the wall of the graft.
Background
The Albograft Vascular Graft is on general sale in Europe, but was only distributed in the US in Pennsylvania. It is an albumin-coated polyester implant, designed to replace or repair an aneurysmal or occluded artery. Unlike uncoated variants coated products typically do not require pre-clotting with the patient’s own blood.
It’s not apparent from the alert what’s occurred here, but last year’s problem was caused by the albumin coating not having been correctly cross-linked, which would render it soluble and as such prone to leakage.
A class I recall is issued by the FDA when a product may cause serious adverse health consequences, including death.
The products featured in the recall are part refs AMC1408, AMC1506, AMC1608, AMC1809, AMC1810, AMC2010, AMC4007, AMC4008, AMC6006, AMC6007, AMC6008, ATC1526, ATC1530, ATC3016, ATC3018, ATC3024, ATC3026, specifically from Batch 56890A.
On June 19 2013, LeMaitre sent an Urgent Field Safety Notice, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and return the affected devices to LeMaitre Vascular who in turn will replace the devices.
Source: FDA