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 Scientific Guider Softip XF Guiding Catheter

  • 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 Scientific Guider Softip XF Guiding Catheter see related information
Date Initiated by Firm July 11, 2007
Date Posted November 24, 2007
Recall Status1 Terminated 3 on December 05, 2007
Recall Number Z-0259-2008
Recall Event ID 38445
510(K)Number K980453  
Product Classification Guiding Catheter - Product Code DQY
Product Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (UPN) H965100420, Catalog Number : 10042, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA
Code Information LOT 9311885, Catalogue #10042, Material #H965100420, Expires 10-JAN-2010 
Recalling Firm/
Manufacturer		 Boston Scientific Target
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact
510-440-7700
Manufacturer Reason
for Recall		 Mislabeling: Catheters were found to be mislabeled (90 cm labeled devices actually contains 100 cm length catheter)
FDA Determined
Cause 2		 Labeling mix-ups
Action Firm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product.
Quantity in Commerce 47 units
Distribution Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.
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 = DQY and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.
-
-