Events

Recall of Device Recall Powerlink (R) System with IntuiTrak Delivery System

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
    53983
  • Event Risk Class
    Class 2
  • Event Number
    Z-0594-2010
  • Event Initiated Date
    2009-11-25
  • Event Date Posted
    2010-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86997
  • 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, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
  • Reason
    This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. if this occurs, treatment may be delayed or interrupted. the firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health.
  • Action
    The recall communication was initiated on 11/25/09 by phone call and followed by recall letter via Fed-Ex Overnight. The recall letter informed the consignees of the reason for recall and products affected. Users were instructed to share this information with physicians that performed the affected procedures at their facility. Endologix informed their consignees that their personnel would retrieve the affected devices and return it to Endologix at no cost and would replace the affected units. Consignees with questions or comments about the notice are directed to (800) 983-2284.

Device

Device Recall Powerlink (R) System with IntuiTrak Delivery System
  • Model / Serial
    MODEL NUMBER 34-34-80LE, LOTS W09-2967 AND W09-3000.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.
  • Product Description
    Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.
  • Manufacturer
    Endologix Inc

Manufacturer

Endologix Inc
  • Manufacturer Address
    Endologix Inc, 11 Studebaker, Irvine CA 92618-2013
  • Source
    USFDA