Z-1115-2007

ThromCat Thrombectomy Catheter System. Catalog number 63000-01

Name: Z-1115-2007 ThromCat Thrombectomy Catheter System. Catalog number 63000-01
Creator: Kensey Nash Corp
Published: 2007-05-21
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2007-05-21 / Terminated

FDA source

Kensey Nash Corp began a recall of ThromCat Thrombectomy Catheter System. Catalog number 63000-01 on 2007-05-21. The reason FDA records is "Defective component (power supply)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1115-2007
Status: Terminated
Initiated: 2007-05-21
Posted: 2007-07-23
Terminated: 2007-08-29
Recalling firm: DSM Biomedical, Inc.
Product: ThromCat Thrombectomy Catheter System. Catalog number 63000-01
Product code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: Defective component (power supply)
FDA root cause: Other
Action: New power supplies were sent directly to Sales Representatives who personally replaced the defective power supplies and returned them to Kensey Nash. A voice mail to all affected KNC Sales Representatives went out on 5/21/07 instructing them to contact the affected accounts immediately.
Quantity in commerce: 11 units
Distribution: Nationwide:The products were shipped to medical facilities in FL, MO, NJ, and TX.
Product codes and lots: Catalog number 63000-01, Lot number 57292 exp March 2008

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)