Events

Recall of OptiVantage DH Injector Suspension System (JBow)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mallinckrodt 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
    47766
  • Event Risk Class
    Class 2
  • Event Number
    Z-1694-2008
  • Event Initiated Date
    2008-04-07
  • Event Date Posted
    2008-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70093
  • 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
    Angiographic Injector & Syringe - Product Code IZQ
  • Reason
    Screws can begin to loosen and shear off to the point of the j-bow falling from the suspension system. this may cause injury to patients or hospital staff.
  • Action
    On April 18, 2008, Mallincrodt Inc. issued an Urgent Device Correction letter informing customers to check their inventory, and determine if they have any defective system units. If they observe any loose screws, sheared screws and/or elongated opening(s) around the screws, they are to immediately take the system out of service and contact the firm's service representative. Covidien's customers were all asked to inspect their inventories and to complete an 'Effectiveness Check Return Form' whether or not the product is defective. However, only those system units observed to have loose screws, sheared screws, and/or elongated openings around the screws, will be scheduled to receive correction by a Covidien Service Representative.

Device

OptiVantage DH Injector Suspension System (JBow)
  • Model / Serial
    Catalog #V8400, Part No. 241078 & Catalog #V8402, Part #241079
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product is distributed in the US throughout the following states: AL, AR, AZ, CA, CO ,CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WV.
  • Product Description
    The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipment. The J-Bow component is used to connect the powerhead to a suspension system.
  • Manufacturer
    Mallinckrodt Inc

Manufacturer

Mallinckrodt Inc
  • Manufacturer Address
    Mallinckrodt Inc, 2111 E Galbraith Rd, Cincinnati OH 45237-1624
  • Source
    USFDA