Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One 40 um Cell Strainer. Single-user, 0.014" guidewire compatible intravascular extraction and aspiration catheter, Part number 1450-0001 size 4.2F, and part number 1451-003 size 5.8F, distributed by Volcano Corporation.
FDA Recall Z-0445-2011 · Posted 2010-11-23
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Recalling FirmVolcano Corporation
Recall StatusTerminated
Product CodeOGX
Date Initiated2010-11-03
Date Terminated2011-12-07
Product Quantity4724 units
Reason for Recall
Potential for product failure. Packaging/Storage issue results in compromised integrity and potential product failure during use, leading to potential patient injury.
Firm Action
Firm initiated recall on 11/03/2010, and sent notifications to its consignees via letter. The firm has requested that consignees provide the notification to all personnel within the organization and letters will be sent directly to known customers on 11/04/2010 by Volcano. Customers have been instructed to cease use and contact customer service to arrange returns, and credit will be issued.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution: USA, Greece, Egypt, Kuwait, Netherlands, Saudi Arabia, Italy, France, Sweden, Portugal, Great Britain, Austria, Switzerland, Germany, Romania, Poland, and Bulgaria
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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