Z-0577-03

Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10

Name: Z-0577-03 Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10
Creator: Cook Biotech, Inc.
Published: 2002-12-13
License: https://open.fda.gov/license/

Cook Biotech, Inc. / initiated 2002-12-13 / Terminated

FDA source

Cook Biotech, Inc. began a recall of Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10 on 2002-12-13. The reason FDA records is "Adverse events- suspected pseudoaneurysm". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0577-03
Status: Terminated
Initiated: 2002-12-13
Posted: 2003-02-26
Terminated: 2003-05-27
Recalling firm: Cook Biotech, Inc.
Product: Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10.
Product code: DXY Implantable Pacemaker Pulse-Generator
Reason for recall: Adverse events- suspected pseudoaneurysm
FDA root cause: Other
Action: The remaining stocks were picked up at the hospital consignees on December 13 and 17, 2002.
Quantity in commerce: 153
Distribution: Indiana
Product codes and lots: lots SB102671, SB102908, LB203536, SB10189, SB101148, SB101402, SB102006 and SB102670.

Product code DXY

K001785Class IISurgisis Peripheral Vascular PatchCook Biotech, Inc. / cleared 2000-12-27

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)