Events

Recall of Device Recall Surgisis peripheral vascular patch

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

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
    25286
  • Event Risk Class
    Class 2
  • Event Number
    Z-0577-03
  • Event Initiated Date
    2002-12-13
  • Event Date Posted
    2003-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-05-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25535
  • 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
    Implantable Pacemaker Pulse-Generator - Product Code DXY
  • Reason
    Adverse events- suspected pseudoaneurysm.
  • Action
    The remaining stocks were picked up at the hospital consignees on December 13 and 17, 2002.

Device

Device Recall Surgisis peripheral vascular patch
  • Model / Serial
    lots SB102671, SB102908, LB203536, SB10189, SB101148, SB101402, SB102006 and SB102670.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Indiana
  • Product Description
    Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10.
  • Manufacturer
    Cook Biotech, Inc.

Manufacturer

Cook Biotech, Inc.
  • Manufacturer Address
    Cook Biotech, Inc., 3055 Kent Avenue, West Lafayette IN 47906
  • Source
    USFDA