Z-0638-04

HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers...

Name: Z-0638-04 HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers...
Creator: Datascope Corporation
Published: 2003-12-30
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2003-12-30 / Terminated

FDA source

Datascope Corporation began a recall of HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT... on 2003-12-30. The reason FDA records is "Water permeability of the patch is out of specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0638-04
Status: Terminated
Initiated: 2003-12-30
Posted: 2004-07-20
Terminated: 2006-01-19
Recalling firm: Datascope Corp.
Product: HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; HEK25/100CPUT; HEK12/75CPUT; HEK10/150CPUT.
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: Water permeability of the patch is out of specification.
FDA root cause: Other
Action: Recall letters were sent to the customers via US Mail return receipt on 12/30/2003.
Quantity in commerce: 710 units
Distribution: The product has been shipped nationwide to 53 hospitals, 4 government hospitals, and 3 sales representatives.
Product codes and lots: Lot Numbers: 03G03; 03H08; 03J25; 03G10; 03H28; 03K02; 03G17; 03J04; 03K09; 03G24; 03J11; 03K16; 03G31; 03J18; 03K23.

Product code DSY

K983819Class IIIntergard Knitted Ultra Thin Collagen Coated Vascular Graft and Hemacarotid Patch Ultra ThinIntervascular, Inc. / cleared 1998-11-24

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)