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 Ultraflex Uncovered Tracheobronchial Stent 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 Ultraflex Uncovered Tracheobronchial Stent Systemsee related information
Date Initiated by FirmJuly 15, 2010
Date PostedAugust 31, 2010
Recall Status1 Terminated 3 on October 14, 2011
Recall NumberZ-2325-2010
Recall Event ID 56331
510(K)NumberK012883 
Product Classification Prosthesis, tracheal, expandable - Product Code JCT
ProductBoston Scientific Ultraflex Uncovered Tracheobronchial Stent System - Proximal Release (10/4) Material/UPN/Catalog Number: M00564670
Code Information Lot/Batch Number: 13485289
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact
508-683-8000
Manufacturer Reason
for Recall		Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
FDA Determined
Cause 2		Process control
ActionBoston Scientific issued "Urgent Medical Device Recall - Immediate Action Required" letters dated July 15,2010 to consignees. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Foreign accounts received notification translated into the local language and with changes that are applicable to local regulations. Boston Scientific can be contacted at 1-508-683-4427.
Quantity in Commerce1 unit
DistributionWorldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JCT
-
-