Z-0445-2011

Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two...

Name: Z-0445-2011 Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two...
Creator: Volcano Corporation
Published: 2010-11-03
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2010-11-03 / Terminated / root cause: design

FDA source

Volcano Corporation began a recall of Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock... on 2010-11-03. The reason FDA records is "Potential for product failure. Packaging/Storage issue results in compromised integrity and potential product failure during use, leading to potential patient injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0445-2011
Status: Terminated
Initiated: 2010-11-03
Posted: 2010-11-23
Terminated: 2011-12-07
Recalling firm: Volcano Corporation
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.
Product code: OGX
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.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Part number 1450-001 size 4.2F and 1451-003 size 5.8F, all lots.

Product code OGX

K071529Class IIXtract Catheter SystemLumen Biomedical, Inc. / cleared 2007-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)