Class 2 Device Recall QuickCat

• Date Initiated by Firm: July 01, 2010
• Date Posted: August 09, 2010
• Recall Status: Terminated on August 20, 2010
• Recall Number: Z-2190-2010
• Recall Event ID: 56115
• 510(K)Number: K060092 K073519
• Product Classification: Extraction catheter - Product Code DXE
• Product: Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.
• Code Information: Lot numbers FQT09K07A through FQT10F09A.
• Recalling Firm/ Manufacturer: Spectranetics Corporation; 96 Talamine Ct; Colorado Springs CO 80907-5159
• For Additional Information Contact: 719-447-2539
• Manufacturer Reason for Recall: Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
• FDA Determined Cause: Process control
• Action: Consignees were notified by letter on Jul 1, 2010, and told to not use affected lots and to contact Spectranetics to arrange a product exchange. More information is available at 800-231-0978.
• Quantity in Commerce: 5080 units (1778 US, 3302 Non-US)
• Distribution: Worldwide distribution: USA, Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, French Polynesia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, and Venezuela.
• 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 = DXE