Events

Recall of Device Recall AlboGraft Knitted with Collagen

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LeMaitre Vascular, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65553
  • Event Risk Class
    Class 1
  • Event Number
    Z-1754-2013
  • Event Initiated Date
    2013-06-17
  • Event Date Posted
    2013-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119543
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Graft, vascular, synthetic/biologic composite - Product Code MAL
  • Reason
    Blood blushing/leaking from the surface of the graft after implantation.
  • Action
    LeMaitre Vascular, Inc.sent an Urgent Field Safety Notice daed 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 device to MeMaitre Vascular which they will replace with a new unit. Customers with questions were instructed to call 781-221-2266, ext. 183. For questions regarding this recall call 781-425-1670, ext 108.

Device

Device Recall AlboGraft Knitted with Collagen
  • Model / Serial
    Lot number/Expiration Date  56890A 2015-04
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.
  • Product Description
    AlboGraft Knitted with Collagen, Straight 15x06 || Catalog Number: AMC1506 || AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
  • Manufacturer
    LeMaitre Vascular, Inc.

Manufacturer

LeMaitre Vascular, Inc.
  • Manufacturer Address
    LeMaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
  • Manufacturer Parent Company (2017)
    LeMaitre Vascular, Inc.
  • Source
    USFDA