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U.S. Department of Health and Human Services

Class 2 Device Recall Lumen Biomedical Xtract Aspiration Catheter system

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  Class 2 Device Recall Lumen Biomedical Xtract Aspiration Catheter system see related information
Date Initiated by Firm November 03, 2010
Date Posted November 23, 2010
Recall Status1 Terminated 3 on December 07, 2011
Recall Number Z-0445-2011
Recall Event ID 57282
510(K)Number K071529  
Product Classification intravascular catheter - Product Code OGX
Product 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.
Code Information Part number 1450-001 size 4.2F and 1451-003 size 5.8F, all lots.
Recalling Firm/
Manufacturer		 Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information Contact Nancy Lelicoff
916-638-8008 Ext. 4503
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 4724 units
Distribution Worldwide distribution: USA, Greece, Egypt, Kuwait, Netherlands, Saudi Arabia, Italy, France, Sweden, Portugal, Great Britain, Austria, Switzerland, Germany, Romania, Poland, and Bulgaria
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 = OGX and Original Applicant = LUMEN BIOMEDICAL, INC.
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