Events

Recall of Device Recall Boston Scientific COGNIS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific CRM Corp.

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
    51713
  • Event Risk Class
    Class 2
  • Event Number
    Z-1678-2009
  • Event Initiated Date
    2009-03-23
  • Event Date Posted
    2009-07-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81059
  • 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
    Cardiac Resynchronization Therapy Defibrillator - Product Code LWP
  • Reason
    Lead connection issues or fracture increases probability of inappropriate therapy: inappropriate shocks, inappropriate anti-tachycardia pacing therapy, or inappropriate inhibition of needed bradycardia pacing therapy.
  • Action
    Boston Scientific sent an Urgent Medical Device Information letter, dated March 23, 2009, to physicians following implanted devices. The letter described the issue, the rate of occurance and provided Patient Management Recommendations.

Device

Device Recall Boston Scientific COGNIS
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States including Guam, Puerto Rico, and U.S. - Virgin Islands. OUS to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, China, Cocos (Keeling) Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, Gabon, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Jordan, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, Tunisia, United Arab Emirates, United Kingdom and Venezuela.
  • Product Description
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107, P108. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • Manufacturer Address
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA