Datascope Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Datascope Corporation
Lot Codes / Batch Numbers
Lot Numbers: 03G03, 03H08, 03J25, 03G10, 03H28, 03K02, 03G17, 03J04, 03K09, 03G24, 03J11, 03K16, 03G31, 03J18, 03K23.
Products Sold
Lot Numbers: 03G03; 03H08; 03J25; 03G10; 03H28; 03K02; 03G17; 03J04; 03K09; 03G24; 03J11; 03K16; 03G31; 03J18; 03K23.
Datascope Corporation is recalling HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog due to Water permeability of the patch is out of specification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Water permeability of the patch is out of specification.
Recommended Action
Per FDA guidance
Recall letters were sent to the customers via US Mail return receipt on 12/30/2003.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026