Events

Recall of Device Recall Beacon Tip Torcon NB Advantage Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook 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
    71692
  • Event Risk Class
    Class 1
  • Event Number
    Z-2317-2015
  • Event Initiated Date
    2015-07-02
  • Event Date Posted
    2015-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138757
  • 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, diagnostic - Product Code DQO
  • Reason
    Reports of catheter tip splits and or separation. loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
  • Action
    Cook Medical sent an Urgent Medical Device Recall letter dated July 2, 2015, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification and instructions for returning the affected product. All customers were notified via courier. Customers with questions were instructed to contact Cook Medical Customer Relations at (800) 457-4500 or (812) 339-2235. Firm issued press release 8/3/2015.

Device

Device Recall Beacon Tip Torcon NB Advantage Catheter
  • Model / Serial
    All Lots of following Product numbers: HNBR4.0-35-100-P-NS-0, HNBR4.0-35-100-P-NS-C1, HNBR4.0-35-100-P-NS-C2, HNBR4.0-35-100-P-NS-CANADA-041480, HNBR4.0-35-100-P-NS-DAV, HNBR4.0-35-100-P-NS-H1, HNBR4.0-35-100-P-NS-JB1,  HNBR4.0-35-100-P-NS-JB2, HNBR4.0-35-100-P-NS-JB3,  HNBR4.0-35-100-P-NS-JIM,  HNBR4.0-35-100-P-NS-KMP,  HNBR4.0-35-100-P-NS-MPA, HNBR4.0-35-100-P-NS-O1,  HNBR4.0-35-100-P-NS-SIM1,  HNBR4.0-35-100-P-NS-SIM2,  HNBR4.0-35-100-P-NS-SIM3, HNBR4.0-35-100-P-NS-VERT,  HNBR4.0-35-100-P-NS-VTK,  HNBR4.0-35-100-P-NS-WNBG,  HNBR4.0-35-125-P-NS-0, HNBR4.0-35-125-P-NS-DAV,  HNBR4.0-35-125-P-NS-H1,  HNBR4.0-35-125-P-NS-JB1,  HNBR4.0-35-125-P-NS-JB2, HNBR4.0-35-125-P-NS-MPA,  HNBR4.0-35-125-P-NS-SIM2,  HNBR4.0-35-125-P-NS-VERT,  HNBR4.0-35-125-P-NS-VTK, HNBR4.0-35-125-P-NS-WNBG,  HNBR4.0-35-40-P-NS-KMP,  HNBR4.0-35-65-P-NS-0,  HNBR4.0-35-65-P-NS-C1, HNBR4.0-35-65-P-NS-C2,  HNBR4.0-35-65-P-NS-C3,  HNBR4.0-35-65-P-NS-DAV,  HNBR4.0-35-65-P-NS-H1,  HNBR4.0-35-65-P-NS-JB1, HNBR4.0-35-65-P-NS-KMP,  HNBR4.0-35-65-P-NS-MPA,  HNBR4.0-35-65-P-NS-RC1,  HNBR4.0-35-65-P-NS-RC2, HNBR4.0-35-65-P-NS-RDC,  HNBR4.0-35-65-P-NS-RIM,  HNBR4.0-35-65-P-NS-SIM1,  HNBR4.0-35-65-P-NS-SIM2, HNBR4.0-35-80-P-NS-C1,  HNBR4.0-35-80-P-NS-C2,  HNBR4.0-35-80-P-NS-JL2,  HNBR4.0-35-80-P-NS-JL2.5, HNBR4.0-35-80-P-NS-JL3,  HNBR4.0-35-80-P-NS-JR1,  HNBR4.0-35-80-P-NS-JR2,  HNBR4.0-35-80-P-NS-JR3.5, HNBR4.0-35-80-P-NS-RH,  HNBR4.0-35-80-P-NS-RLG,  HNBR4.0-35-80-P-NS-VS,  HNBR4.0-35-80-P-NS-VS1, HNBR4.0-35-80-P-NS-VS2,  HNBR4.0-35-80-P-NS-VS3,  HNBR4.0-NT-100-P-NS-H1,  HNBR4.0-NT-80-P-NS-RC1, HNBR4.0-NT-80-P-NS-RIM,  HNBR4.0-NT-80-P-NS-RLG, HNBR4.1-35-100-P-NS-0,  HNBR4.1-35-100-P-NS-C1, HNBR4.1-35-100-P-NS-C2,  HNBR4.1-35-100-P-NS-DAV,  HNBR4.1-35-100-P-NS-H1,  HNBR4.1-35-100-P-NS-JB1, HNBR4.1-35-100-P-NS-JB2,  HNBR4.1-35-100-P-NS-JB3,  HNBR4.1-35-100-P-NS-KMP,  HNBR4.1-35-100-P-NS-MPA, HNBR4.1-35-100-P-NS-O1,  HNBR4.1-35-100-P-NS-SIM1,  HNBR4.1-35-100-P-NS-SIM2,  HNBR4.1-35-100-P-NS-SIM3, HNBR4.1-35-100-P-NS-VERT,  HNBR4.1-35-100-P-NS-WNBG,  HNBR4.1-35-110-P-NS-JB1,  HNBR4.1-35-110-P-NS-JB2, HNBR4.1-35-110-P-NS-WNBG,  HNBR4.1-35-120-P-NS-JB2,  HNBR4.1-35-130-P-NS-DAV-T,  HNBR4.1-35-40-P-NS-KMP, HNBR4.1-35-65-P-NS-C1,  HNBR4.1-35-65-P-NS-C2,  HNBR4.1-35-65-P-NS-DAV,  HNBR4.1-35-65-P-NS-H1,  HNBR4.1-35-65-P-NS-JB1, HNBR4.1-35-65-P-NS-KMP,  HNBR4.1-35-65-P-NS-LEV1,  HNBR4.1-35-65-P-NS-MPA,  HNBR4.1-35-65-P-NS-RC1, HNBR4.1-35-65-P-NS-RC2,  HNBR4.1-35-65-P-NS-RDC,  HNBR4.1-35-65-P-NS-RIM,  HNBR4.1-35-65-P-NS-SHK1.0, HNBR4.1-35-65-P-NS-SIM1,  HNBR4.1-35-75-P-NS-CHG-D,  HNBR4.1-35-80-P-NS-C1,  HNBR4.1-35-80-P-NS-C2, HNBR4.1-35-80-P-NS-JL2,  HNBR4.1-35-80-P-NS-JL2.5,  HNBR4.1-35-80-P-NS-JL3,  HNBR4.1-35-80-P-NS-JR1, HNBR4.1-35-80-P-NS-JR2,  HNBR4.1-35-80-P-NS-JR3.5,  HNBR4.1-35-80-P-NS-RC1,  HNBR4.1-35-80-P-NS-RH, HNBR4.1-35-80-P-NS-RLG,  HNBR4.1-35-80-P-NS-VS,  HNBR4.1-35-80-P-NS-VS2,  HNBR4.1-NT-100-P-NS-H1, HNBR4.1-NT-80-P-NS-C1,  HNBR4.1-NT-80-P-NS-RC1,  HNBR4.1-NT-80-P-NS-RH,  HNBR4.1-NT-80-P-NS-RIM, HNBR4.1-NT-80-P-NS-RLG,  HNBR5.0-35-65-P-NS-RUC, HNBR5.0-35-90-P-NS-RUC
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • Product Description
    Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Manufacturer Address
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA