• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall FastCath

  • 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 FastCath see related information
Date Initiated by Firm October 05, 2006
Date Posted March 01, 2007
Recall Status1 Terminated 3 on May 25, 2007
Recall Number Z-0535-2007
Recall Event ID 36605
510(K)Number K964518  
Product Classification Transseptal Catheter Introducer - Product Code DYB
Product FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.
Code Information Lot number 1239904
Recalling Firm/
St. Jude Medical / Daig Division
14901 Deveau Pl
Minnetonka MN 55345-2126
Manufacturer Reason
for Recall
Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.
FDA Determined
Cause 2
Action The affected customers were notified on 10/5/06 by letter.
Quantity in Commerce 40 Units
Distribution Nationwide.
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.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = DAIG CORP.