Events

Recall of 9F Pruitt F3 Outlying Carotid Shunt with Tport

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
    60007
  • Event Risk Class
    Class 2
  • Event Number
    Z-0070-2012
  • Event Initiated Date
    2011-10-04
  • Event Date Posted
    2011-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104225
  • 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, intravascular occluding, temporary - Product Code MJN
  • Reason
    Extended expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05.
  • Action
    The firm, LeMaitre Vascular, Inc., sent an "URGENT: 9F PRUITT F3 Carotid Shunt Device Field Safety Notice" dated October 4, 2011 to its customers. The notice describes the product, problem and action to be taken. The customers were instructed to identify their inventory; return the affected products for exchange with a properly labeled device; contact Le Matire customer service for replacement at 800-628-9470, and complete and return the RECALL NOTICE RECONCILIATION FORM via fax to 781-425-5049, even if no product is on hand. If you have any questions concerning this safety notice, please contact the Quality Assurance Engineer at 781-221-2266 ext. 183.

Device

9F Pruitt F3 Outlying Carotid Shunt with Tport
  • Model / Serial
    Lot Number: PFT2209
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: CA, FL, IA, IL, MA, MI, NE, NJ, NY, OH, SC, TX, and WI.
  • Product Description
    LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port || The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the Shunt when it is placed within the common and internal carotid arteries. An external safety balloon located on the inflation arm leading to the distal (internal carotid) balloon acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above optimal size and pressure. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage. The Pruitt F3 Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. The sleeve of the external safety balloon is yellow, to increase its visibility. Depth markings on the shunt body are for reference during insertion
  • Manufacturer
    Lemaitre Vascular, Inc.

Manufacturer

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