  |
LeMaitre Vascular, Inc., Albograft Vascular Graft: Class I Recall - Blood Leak
Models: AMC1408, AMC1506, AMC1608, AMC1809, AMC1810, AMC2010, AMC4007, AMC4008, AMC6006, AMC6007, AMC6008, ATC1526, ATC1530, ATC3016, ATC3018, ATC3024, ATC3026, Batch 56890A
AUDIENCE: Risk Manager, Cardiology, Surgery
ISSUE: LeMaitre Vascular, Inc. recalled the Albograft Vascular Graft due to blood leaking from the surface of the graft after implantation. This product may cause serious adverse health consequences, including death.
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.
BACKGROUND: 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.
RECOMMENDATION: On June 19 2013, the firm sent an Urgent Field Safety Notice dated June 19, 2013, to all affected customers. Customers were instructed to identify and return the affected devices to LeMaitre Vascular. They in turn will replace the devices.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
