Events

Recall of 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.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datascope Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28388
  • Event Risk Class
    Class 2
  • Event Number
    Z-0638-04
  • Event Initiated Date
    2003-12-30
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31748
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter - Product Code DSY
  • Reason
    Water permeability of the patch is out of specification.
  • Action
    Recall letters were sent to the customers via US Mail return receipt on 12/30/2003.

Device

HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. || Product Catal...
  • Model / Serial
    Lot Numbers: 03G03; 03H08; 03J25; 03G10; 03H28; 03K02; 03G17; 03J04; 03K09; 03G24; 03J11; 03K16; 03G31; 03J18; 03K23.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • Manufacturer Address
    Datascope Corporation, 14 Philips Pkwy, Montvale NJ 07645-1811
  • Source
    USFDA