Z-0597-2007

ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use...

Name: Z-0597-2007 ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use...
Creator: Kensey Nash Corp
Published: 2007-02-07
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2007-02-07 / Terminated

FDA source

Kensey Nash Corp began a recall of ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform... on 2007-02-07. The reason FDA records is "Face seal may wear excessively and cause particulate matter". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0597-2007
Status: Terminated
Initiated: 2007-02-07
Posted: 2007-03-08
Terminated: 2007-06-12
Recalling firm: DSM Biomedical, Inc.
Product: ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow.
Product code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: Face seal may wear excessively and cause particulate matter.
FDA root cause: Other
Action: On 2/7/07, a voice mail message was sent to all KNC Sales Representatives instructing them to contact affected accounts immediately. On 2/9/07, recall notices were faxed to all affected accounts that had affected product. The recall notices instructed hospitals to quarantine the affected lots and to contact their KNC Sales Representative to arrange for retrieval of the product.
Quantity in commerce: 165 units
Distribution: Nationwide.
Product codes and lots: Lot number 54877 exp December 2007, Lot number 55318 exp January 2008, Lot number 55218 exp January 2008, and Lot number 54821 exp December 2007

Product code MCW

K060016Class IIThromcat Thrombectomy Catheter SystemKensey Nash Corp. / cleared 2006-04-25

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)