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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-0791-04
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 44 cm, Coronary Sinus - Multi-Purpose Tip Shape, CS-MP, REF 6716
Code Information Lot 4021651
Recalling Firm/
Manufacturer		 Guidant Corp-Cpi Division
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact Steven C. Roth
651-582-4260
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		 Other
Action Starting on March 11, 2003, the firm''s representatives visited consignees, to whom the recalled catheters had been consigned, and retrieved the 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.
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