Events

Recall of Device Recall ConQuest PTA Dilation Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Peripheral Vascular 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
    70839
  • Event Risk Class
    Class 2
  • Event Number
    Z-1413-2015
  • Event Initiated Date
    2015-03-23
  • Event Date Posted
    2015-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135055
  • 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, percutaneous - Product Code DQY
  • Reason
    Bard peripheral vascular is recalling the bard conquest pta balloon dilatation catheter because it may be at risk of having deflation related issues.
  • Action
    Bard sent an Urgent Medical Device Recall Notification letter dated March 23, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informs the customers that the product code and lot combination listed on the attachment 1 of the recall letter may be at risk of having deflation related issues. Customers are instructed to complete and return the Effectiveness Check Form. Customers with questions are instructed to call Bard Peripheral Vascular's (BPV) at (800) 321-4254 option #2 Ext 2501 (M-F 7am-4pm MST) Customers are instructed to fax the recall and effectiveness check form to BPV at (800) 994-6772.

Device

Device Recall ConQuest PTA Dilation Catheter
  • Model / Serial
    Lot No. REYA0973, REYA2566, REYC0372, REYC0950, REYC1426, REYC2200, REYC2365, REYC2825, REYC2575
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including Puerto Rico and the countries of : Austria, Belgium, Germany, France, Greece, Iran, Ireland, Israel, Martinique, Netherlands, Portugal, Russia, Slovenia, South Africa, Spain, United Arab Emirates (UAE), United Kingdom, Canada, Korea, Taiwan, Singapore, Thailand, Chile, Guam, Mexico, Malaysia and Australia.
  • Product Description
    Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Manufacturer Address
    Bard Peripheral Vascular Inc, 1625 W 3rd St Ste 109, Tempe AZ 85281-2438
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA