The Food and Drug Administration (“FDA”) is recalling a vascular graft device that may allow blood to leak after implantation. The blood leaks could be serious enough to cause significant health problems, including death.
The device subject of the recall — the Albograft Vascular Graft — is manufactured by LeMaitre Vascular Inc.
Within the United States, the device was distributed in Pennsylvania only, between April 2011 and June 2013.
The Alborgraft Vascular Graft is made from a synthetic material that is designed to repair arteries damaged due to certain aneurysms or blockages, called “occlusions” caused by disease.
In light of the risk, the FDA has issued a Class 1 Recall — the most serious and urgent level of recall which occurs only when there is ” a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or deatha”.
Affected models are: AMC1408, AMC1506, AMC1608, AMC1809, AMC1810, AMC2010, AMC4007, AMC4008, AMC6006, AMC6007, AMC6008, ATC1526, ATC1530, ATC3016, ATC3018, ATC3024, ATC3026, Batch 56890A