Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Powerlink (R) System with IntuiTrak Delivery System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Powerlink (R) System with IntuiTrak Delivery System see related information
Date Initiated by Firm November 25, 2009
Date Posted January 11, 2010
Recall Status1 Terminated 3 on May 07, 2010
Recall Number Z-0594-2010
Recall Event ID 53983
PMA Number P040042 
Product Classification Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Product Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.
Code Information MODEL NUMBER 34-34-80LE, LOTS W09-2967 AND W09-3000.
Recalling Firm/
Manufacturer		 Endologix Inc
11 Studebaker
Irvine CA 92618-2013
For Additional Information Contact
949-595-7200
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Process design
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.
Quantity in Commerce 14 UNITS DISTRIBUTED: 3 LOT W09-2967 AND 1 LOT W09-3000 STILL AT CONSIGNEES. 10 UNITS USED.
Distribution Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = OAD and Original Applicant = IRVINE BIOMEDICAL,INC.(IBI)
-
-