Class 2 Device Recall Guidant

• Date Initiated by Firm: March 11, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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/ 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: 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.
• 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