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U.S. Department of Health and Human Services

Class 2 Device Recall Guidant

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  Class 2 Device Recall Guidant see related information
Date Initiated by Firm March 11, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 31, 2005
Recall Number Z-0790-04
Recall Event ID 28498
510(K)Number K021284  K021455  
Product Classification Cannula, Catheter - Product Code DQR
Product Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, CS Wide Tip Shape, CS-W, REF 6705
Code Information Lots 4012251, 4012451, 4012851, 4012951, 4020451, 4021951, and 4022551 
Recalling Firm/
Guidant Corp-Cpi Division
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact Steven C. Roth
Manufacturer Reason
for Recall
The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.
FDA Determined
Cause 2
Action Starting on March 11, 2003, the firm''s representatives visited consignees, to whom the recalled catheters had been consigned, and retrieved the catheters.
Quantity in Commerce 213 catheters
Distribution Nationwide in the United States.
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 = DQR and Original Applicant = GUIDANT CORP.