Albograft Surgical Graft Recall Issued After Bleeding Incident
A vascular graft that is used to seal damaged arteries has been recalled, due to a potential risk that it may cause serious injury or death.
The Albograft Vascular Graft recall was posted by the FDA on Wednesday, and has been designated as a class I medical device recall, suggesting that the federal regulatory agency believes that continued use of the device poses a substantial risk for patients.
The manufacturer, LeMaitre Vascular, Inc. of Burlington, Massachusetts, sent an Urgent Field Safety Notice out to customers on June 19, warning that reports suggest blood may leak through the surface of the grafts after implantation. The Albograft is a synthetic graft used to repair or replace arteries damaged by an aneurysm or blockage caused by disease.
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The recall affects Albograft Vascular Grafts manufactured in April 2011 and distributed between April 2011 and June 2013. The recall affects batch 56890A and model numbers AMC1408, AMC1506, AMC1608, AMC1809, AMC1810, AMC2010, AMC4007, AMC4008, AMC6006, AMC6007, AMC6008, ATC1526, ATC1530, ATC3016, ATC3018, ATC3024, and ATC3026.
The Class I medical device recall designation is the most serious classification of recall the FDA can declare. It means that the agency believes that there is a reasonable probability that the recalled product will cause severe injury or death. However, there have been no reported injuries or deaths to date.
The manufacturer has instructed customers to identify and return the affected grafts to LeMaitre Vascular, which will replace them with other grafts. The company has also visited customers and had its representatives remove the devices.
Customers with questions can call LeMaitre Vascular at 781-221-2266, extension 183. The FDA requests that health care professionals and consumers who experience an adverse event related to this device report such incidents to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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