Events

Recall of Device Recall Hemashield Double Velour Cardiovascular Fabrics.

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

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
    56004
  • Event Risk Class
    Class 2
  • Event Number
    Z-2062-2010
  • Event Initiated Date
    2010-05-24
  • Event Date Posted
    2010-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92406
  • 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
    Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
  • Reason
    Various hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.
  • Action
    Letters were sent by Federal Express commencing July 12, 2010. Distribution has to be obtained from Boston Scientific. Questions are directed to the local Sales/Service Representative, or to the firm's Customer Service at 1-888-880-2874.

Device

Device Recall Hemashield Double Velour Cardiovascular Fabrics.
  • Model / Serial
    xxx
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Hemashield Double Velour Cardiovascular Fabrics.
  • Manufacturer
    Maquet Cardiovascular, LLC

Manufacturer

Maquet Cardiovascular, LLC
  • Manufacturer Address
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA