Events

Recall of Device Recall Bard Denali IVC Filter

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
    72945
  • Event Risk Class
    Class 2
  • Event Number
    Z-0737-2016
  • Event Initiated Date
    2015-03-13
  • Event Date Posted
    2016-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142563
  • 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
    Filter, intravascular, cardiovascular - Product Code DTK
  • Reason
    Ifu missing contraindications: patients with uncontrolled sepsis and patients with known hypersensitivity to nickel-titanium alloys.
  • Action
    The firm sent out Medical Device Recall customer notification letters on 03/13/15. The notification letter stated that there is no required action on the customer's part. Customers were told that if the device did not meet their needs then the firm will provide a replacement unit. Effective immediately the firm is implementing a change in the ordering code for the device to accurately reflect the approved information with the IFU and corresponding retrieval kit. Any questions the firm states to call Bard Canada: 1-800-268-2862 Western Canada 1-800-387-9473 Ontario 1-800-387-7851 Eastern Canada

Device

Device Recall Bard Denali IVC Filter
  • Model / Serial
    Product Code: DL950J Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699  Product Code: DL950F Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to CA only.
  • Product Description
    Denali Filter-Jugular/Subclavian DL950J || Denali Filter-Femoral Delivery DL950F. || Intravascular filters.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

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