Events

Recall of ULTIMA OPCAB System

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
    66365
  • Event Risk Class
    Class 2
  • Event Number
    Z-0001-2014
  • Event Initiated Date
    2013-09-20
  • Event Date Posted
    2013-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122158
  • 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
    Cardiovascular surgical instruments tray (kit) - Product Code OFA
  • Reason
    Maquet has identified a potential issue with the ultima opcab (part numbers om-2003s & om-2001d). labeling for the 2 blade lots had been incorrectly applied. the standard blades from lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from lot #25052200 were incorrectly labeled as standard blades.
  • Action
    MAQUET sent an "Urgent Medical Device Recall" letter and "Field Recall Response Forms" dated September 20, 2013 to customers via Federal Express. The notification identifies the affected product; informs the customers of the nature of the issue; and advises of potential adverse patient consequences that may occur. The customer is asked to complete and return the Field Recall Response Form. If the customer has questions they are directed to contact their field representative or MAQUET Technical Support (888.627.8383 between 8 am and 5 pm EST Monday through Friday).

Device

ULTIMA OPCAB System
  • Model / Serial
    ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200).
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.
  • Product Description
    Ultima OPCAB System, Sterile, Rx Only, || Product Usage: || Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart.
  • 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