HemaCarotid Patch, Ultrathin, Collagen Coated Knitted… recallZ-0638-04 · Datascope Corporation · initiated Dec 30, 2003
Terminated All recalls posted in July 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Datascope Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Water permeability of the patch is out of specification.
FDA root cause category: Other
What the company is doing
Recall letters were sent to the customers via US Mail return receipt on 12/30/2003.
Recall details
- Recall number
- Z-0638-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 30, 2003
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- Datascope Corporation
- Quantity
- 710 units
- Product code
- DSY
- FDA submissions
- K983819
- Distribution
- The product has been shipped nationwide to 53 hospitals, 4 government hospitals, and 3 sales representatives.
Product description
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.
Code information (models, lots, serial numbers)
Lot Numbers: 03G03; 03H08; 03J25; 03G10; 03H28; 03K02; 03G17; 03J04; 03K09; 03G24; 03J11; 03K16; 03G31; 03J18; 03K23.
Other devices under the same FDA submission
13 devices cleared under K983819 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Hemagard Carotid Patch HGKTP08/75CPUT (1)Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter6 reports
- Hemacarotid Patch HEK08/75CPUT (1)Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter5 reports
- Hemagard HGKUT0007-40Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter5 reports
- Hemagard Carotid Patch HGKTP06/75CPUT (1)Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter4 reports
- Hemagard HGKUT0008-40Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 death3 reports
- Intergard IGKUT0008-70Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter2 reports
- Hemacarotid Patch HEK10/75CPUT (1)Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter2 reports
- Hemacarotid Patch HEK14/75CPUT (1)Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter2 reports
- Intergard IGKUT0007-40Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Intergard IGKUT0008-40Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard HGKUT0008-20Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Hemagard Carotid Patch HGK10/75CPUT (1)Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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