Events

Recall of LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml , Length 80 cm Latex || Product Number: 1601-28

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
    31108
  • Event Risk Class
    Class 2
  • Event Number
    Z-0561-05
  • Event Initiated Date
    2005-02-07
  • Event Date Posted
    2005-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37192
  • 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
    Catheter, Embolectomy - Product Code DXE
  • Reason
    Product sterility maybe compromised due to defective packaging.
  • Action
    LaMaitre notified consignees by lettter advising users to check inventory and return defective product.

Device

LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml , Length 80 cm Latex || Pro...
  • Model / Serial
    Lot Number: SLC1205
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, CA, FL, IN, MD, MI,NY, TN, FOREIGN: Germany
  • Product Description
    LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml , Length 80 cm Latex || Product Number: 1601-28
  • Manufacturer
    Lemaitre Vascular, Inc.

Manufacturer

Lemaitre Vascular, Inc.
  • Manufacturer Address
    Lemaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
  • Source
    USFDA