Events

Recall of Device Recall POWERLINK SYSTEM DELIVERY CATHETER

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Endologix 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
    34219
  • Event Risk Class
    Class 2
  • Event Number
    Z-0591-06
  • Event Initiated Date
    2005-12-14
  • Event Date Posted
    2006-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43403
  • 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
    System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
  • Reason
    The tip may separate from the catheter sheath inner core during insertion of the graft. the delivery catheter is being recalled. the implanted devices are not affected.
  • Action
    The three affected hospitals were contacted telephone and in writing (Recall Letters) sent via FedEx Endologix field personnel are scheduled to remove the product units by 12/16/05. Notices for Phase II of recall to 8 additional consignees for 6 additional models (9 lots) being recalled mailed 12/19-12/22/05.

Device

Device Recall POWERLINK SYSTEM DELIVERY CATHETER
  • Model / Serial
    Lot#W05-0511
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    For units still in distribution: AZ, DE, KS, PA, & TN
  • Product Description
    Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
  • Manufacturer
    Endologix Inc

Manufacturer

Endologix Inc
  • Manufacturer Address
    Endologix Inc, 13900 Alton Pkwy Ste 122, Irvine CA 92618-1621
  • Source
    USFDA