Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.
FDA Recall Z-2190-2010 · Posted 2010-08-09
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Recalling FirmSpectranetics Corporation
Recall StatusTerminated
Product CodeDXE
Date Initiated2010-07-01
Date Terminated2010-08-20
Product Quantity5080 units (1778 US, 3302 Non-US)
Reason for Recall
Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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