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U.S. Department of Health and Human Services

Class 2 Device Recall QuickCat

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  Class 2 Device Recall QuickCat see related information
Date Initiated by Firm July 01, 2010
Date Posted August 09, 2010
Recall Status1 Terminated 3 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/
Spectranetics Corporation
96 Talamine Ct
Colorado Springs CO 80907-5159
For Additional Information Contact
Manufacturer Reason
for Recall
Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
FDA Determined
Cause 2
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 and Original Applicant = KENSEY NASH CORP.