Z-2190-2010

Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for...

Name: Z-2190-2010 Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for...
Creator: Spectranetics Corporation
Published: 2010-07-01
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2010-07-01 / Terminated / root cause: manufacturing process

FDA source

Spectranetics Corporation began a recall of Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels on 2010-07-01. The reason FDA records is "Guidewire lumen may be occluded, preventing guidewire insertion into the catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2190-2010
Status: Terminated
Initiated: 2010-07-01
Posted: 2010-08-09
Terminated: 2010-08-20
Recalling firm: Spectranetics Corp.
Product: Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.
Product code: DXE Catheter, Embolectomy
Reason for recall: Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot numbers FQT09K07A through FQT10F09A.

Product code DXE

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)