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 3 Device Recall Boston ScientificRenegade HiFlo Microcatheter Kit

  • 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 3 Device Recall Boston ScientificRenegade HiFlo Microcatheter Kit see related information
Date Initiated by Firm September 10, 2007
Date Posted October 31, 2007
Recall Status1 Terminated 3 on December 20, 2007
Recall Number Z-0109-2008
Recall Event ID 44939
510(K)Number K000177  
Product Classification Microcatheter Kit - Product Code KRA
Product Boston Scientific-Renegade Hi-Flo Microcatheter Kit,
UPN Material Number: MOO1183030,Catalog Number: 18-303
Code Information Lot Numbers: 9218692; 9218628; 9218451
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact
508-650-8798
Manufacturer Reason
for Recall		 Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.
FDA Determined
Cause 2		 Packaging process control
Action Boston Scientific issued a Urgent Medical Device Recall Letter dated September 10, 2007 to Domestic accounts via Federal Express. The notification instructed the account to immediately discontinue the use of the product under this recall, check their inventory, remove any affected product , and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form
Quantity in Commerce 153
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 = KRA and Original Applicant = BOSTON SCIENTIFIC CORP.
-
-