Recall Class: Class I
Date Recall Initiated: June 17, 2013
Product: Albograft Vascular Graft
Models: AMC1408, AMC1506, AMC1608, AMC1809, AMC1810, AMC2010, AMC4007, AMC4008, AMC6006, AMC6007, AMC6008, ATC1526, ATC1530, ATC3016, ATC3018, ATC3024, ATC3026, Batch 56890A
Within the U.S., this device was only distributed in Pennsylvania.
This device was manufactured in April 2011, and distributed from April 2011, through June 2013.
Use: The Albograft Vascular Graft is made of synthetic material. It is designed to replace or repair a damaged artery with an abnormal enlargement (aneurysm) or a blockage (occlusion) caused by a disease.
Lemaitre Vascular, Inc.
63 Second Avenue
Burlington, Massachusetts 01803
Reason for Recall: This product was recalled due to blood leaking from the surface of the graft after implantation. This product may cause serious adverse health consequences, including death.
Public Contact: Customers with questions can contact LeMaitre Vascular at 781-221-2266, ext. 183.
FDA District: New England District Office
On June 19 2013, the firm sent an Urgent Field Safety Notice dated June 19, 2013, 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. They in turn will replace the devices.
LeMaitre Vascular visited the U.S. customer on June 18, 2013, and removed the devices.
Customers who have questions about this recall can call the firm at 781-425-1670, ext. 108.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.