Recall Z-1763-2013— LeMaitre Vascular, Inc.

Name: FDA recall Z-1763-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-17

Class I · Terminated

Class I FDA medical device recall by LeMaitre Vascular, Inc., initiated 2013-06-17, terminated 2016-08-15. It names 2 FDA 510(k) clearances: K103080, K093231. Product: AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.. Reason: Blood blushing/leaking from the surface of the graft after implantation.

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class I
Status: Terminated
Initiated: 2013-06-17
Terminated: 2016-08-15
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K103080 — ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.·cleared 2011-01-19
K093231 — ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.·cleared 2010-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Reason for recall

Blood blushing/leaking from the surface of the graft after implantation

Data sourced from openFDA. This site is unofficial and independent of the FDA.