Events

Recall of Device Recall LeMaitre Vascular AnastoClip AC Closure System

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
    74563
  • Event Risk Class
    Class 2
  • Event Number
    Z-2284-2016
  • Event Initiated Date
    2016-06-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147906
  • 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
    Clip, implantable - Product Code FZP
  • Reason
    Us marketing brochure for the anastoclip ac closure system states that the anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
  • Action
    The firm, LeMaitre Vascular, Inc., sent an "URGENT: Medical Device Correction" letter dated June 20, 2016 to its distributors and hospitals via Priority mail. The letter describes the product, problem and actions to be taken. The customers were informed of the intended use of the devices and the correct catalog numbers to order for the dura application. The customers were instructed to return unused devices for an exchange or refund; destroy any Anastoclip related marketing materials that you have received from Lemaitre between October 25- 2015 and June 15, 2016, and complete and return the reply form for reconciliation of this recall via fax at 781-221-2223, email: CSUS@LEMAITRE.COM or by mail. LeMaitre Vascular, Inc. will replace any affected device with a new device labeled for dura closure or issue a credit per request. Questions concerning this safety notice, please contact me at 781-221-2266 ext. 183.

Device

Device Recall LeMaitre Vascular AnastoClip AC Closure System
  • Model / Serial
    Lot Numbers: ANC1549¿ ANC1612¿ ANC1678¿ ANC1679¿ ANC1682¿ ANC2001¿ ANC2008¿ ANC2009¿ ANC2013¿ ANC2015¿ ANC2016¿ ANC2017¿ ANC2018¿ ANC2019¿ ANC2020¿ ANC2021¿
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    AnastoClip AC 8cm 35 Clips (1 Each} Large || REF # 4000-07 || The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
  • 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