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

Class 2 Device Recall

  • 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 see related information
Date Initiated by Firm October 28, 2005
Date Posted January 06, 2006
Recall Status1 Terminated 3 on February 15, 2007
Recall Number Z-0344-06
Recall Event ID 33858
510(K)Number K991897  
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV Valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66A M001PRTA66AO. Firm on label: Boston Scientific, Natick, MA and Boston Scientific, Glens Falls, NY
Code Information 1012596, 1020903
Recalling Firm/
Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Cindy Finney
Manufacturer Reason
for Recall
Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
FDA Determined
Cause 2
Action Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.
Quantity in Commerce 97 units
Distribution DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan
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 = LJS and Original Applicant = CATHETER INNOVATIONS, INC.