Class 2 Device Recall Cronus

• Date Initiated by Firm: January 27, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on October 31, 2005
• Recall Number: Z-0594-04
• Recall Event ID: 28254
• 510(K)Number: K021363
• Product Classification: unknown device name - Product Code NFN
• Product: Floppy Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-4
• Code Information: Lots 0211-4012, 0307-4037, 0308-4057, and 0308-4058
• Recalling Firm/ Manufacturer: Stereotaxis Inc; 4041 Forest Park Ave; Saint Louis MO 63108-3213
• For Additional Information Contact: Robert W. Calllahan; 314-615-6923
• Manufacturer Reason for Recall: The magnet at the end of the guidewire could break off.
• FDA Determined Cause: Other
• Action: Consignees were sent a notice dated January 27, 2004. The notice requested that consignees stop using the product and stated that a firm representative would contact the consignees. The firm''s representatives have retrieved all of the product at the consignees.
• Quantity in Commerce: 31 guidewires
• Distribution: The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands.

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 = NFN