Events

Recall of Bridge Occlusion Balloon

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

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
    75617
  • Event Risk Class
    Class 2
  • Event Number
    Z-0663-2017
  • Event Initiated Date
    2016-10-31
  • Event Date Posted
    2016-11-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150923
  • 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
    Catheter, intravascular occluding, temporary - Product Code MJN
  • Reason
    Spectranetics corporation announces a voluntary field action for the turbo elite atherectomy catheter, elca coronary atherectomy catheter, and bridge occlusion balloon due to potentially compromised integrity of the outer sterile packaging.
  • Action
    Spectranectics sent an Urgent Medical Device Recall letter dated October 31, 2016, to all affected consignees. Consignees were instructed to discontinue use of the potentially impacted lots and return the product for replacement. Consignees were also instructed to complete the attached Acknowledgement and Receipt Form to facilitate the product return of any remaining product in inventory. Customers with questions were instructed to call 1-800-231-0978, Option 2. For questions regarding this recall call 719-651-8517.

Device

Bridge Occlusion Balloon
  • Model / Serial
    FMN16E11A; FMN16E18A; FMN16E25A; FMN16F01A; FMN16F08A; FMN16F15A FMN16F22A; FMN16G13A; FMN16G19A; FMN16G25A; FMN16H04A; FMN16H23A; FMN16J27A
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.
  • Product Description
    Bridge Occlusion Balloon. Model: 590-001 || Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.
  • Manufacturer
    Spectranetics Corporation

Manufacturer

Spectranetics Corporation
  • Manufacturer Address
    Spectranetics Corporation, 9965 Federal Drive, Colorado Springs CO 80921-3617
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA