Events

Recall of Device Recall Denali FilterJugular Subclavian Delivery System

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
    73365
  • Event Risk Class
    Class 2
  • Event Number
    Z-1068-2016
  • Event Initiated Date
    2016-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143977
  • 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
    Bard peripheral vascular, inc. is recalling denali filter-jugular/subclavian delivery system and denali filter-femoral delivery system because of the stop cocks potentially cracking.
  • Action
    The firm sent customer notification letters on 02/09/16. The following instructions were provided to customers: 1. Do not use or further distribute any affected product. 2. Check all inventory locations within the institution for affected product code/lot number combination listed in the recall notice. If further distributed any of the product code/lot numbers, immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to BPV. 3. Remove any identified product from your shelves. 4. If have used the affected product, complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by this recall has been removed from inventory; 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that you intend to return. It is extremely important the information is received. 6. Call Recall Coordinator Raye Seisinger at 1-800-321-4254 Option #2 Ext 2501 (M-F 6am to 3pm MST) or email at raye.seisinger@crbard.com. Once all information has been verified, the Recall Coordinator will issue either a Return Authorization (XC) Number or Consignment Recall Number (XH) to facilitate the expedient return of the product. BPV will provide replacement product for returned product. 7. E-mail the completed Recall and Effectiveness Check Form to DenaliRecall@crbard.com or fax it to BPV at 1-800-994-6772. If cannot e-mail or FAX the form, please call the BPV recall coordinator (Raye Seisinger, at 1-800-321-4254 Option #2 Ext 2501) and report the required information verbally. 8. A mailing label is enclosed for convenience to return the affected product. Please mark the outside package as "RECALLED PRODUCT" and include the XC or XH number. All products should be returned to the following shipping address: Bard Peripheral Vascular, Inc. 1415 W. 3'd

Device

Device Recall Denali FilterJugular Subclavian Delivery System
  • Model / Serial
    Product # Lot # DL900J GFZJ0450 DL900J GFZJ0452 DL900J GFZJ0455 DL900J GFZK0303 DL900J GFZJ0454 DL900J GFZK0304 DL900J GFZK0306 DL950J GFZJ1176 DL950J GFZJ1177 DL900J GFZK0309 DL900J GFZK0305 DL900J GFZK0308 DL900J GFZJ0456 DL900J GFZK0307 DL900J GFZJ0460 DL900J GFZJ0459 DL900J GFZK0310 DL900J GFZK0311 DL900J GFZK0314 DL900J GFZK0313 DL900J GFZK0312 DL900J GFZK0315 DL900J GFZK0316 DL900J GFZK0317 DL900J GFZK0358 DL900J GFZK0318 DL900J GFZK0319 DL900J GFZK0360 DL900J GFZK0361 DL950J GFZK0350 DL900J GFZK0359 DL900J GFZK0362 DL900J GFZK0363 DL900J GFZK0365 DL900J GFZK0344 DL900J GFZK0345 DL900J GFZK0346 DL950J GFZK2376 DL900J GFZK3551 DL900J GFZK3553 DL900J GFZK3555 DL900J GFZK3552 DL900J GFZK3554 DL900J GFZK3557 DL900J GFZK0340 DL900J GFZK0341 DL900J GFZK0342 DL900J GFZK0343 DL900J GFZK0348 DL900J GFZK0349 DL900J GFZK3556 DL900J GFZK0347 DL900J GFZK3558 DL900J GFZK3559 DL900J GFZK3560 DL900J GFZK3561
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) including DC and PR, and the states of MN, TX, PA, OH, IL, OR, CA, SC, NC, AK, NY, MD, GA, NJ, AZ, KY, OH, WI, AL, AR, MO, FL, MA, MT, TN, LA, CT, NE, WV, VA, NV, ME, UT, CO, WY, AR, DE, NM, IN, MN, MS, NH, IA, MI, WA, VA, KS, HI, RI, SD, VT, and the countries of Hong Kong, Malaysia, Canada, Chile.
  • Product Description
    Denali Filter-Jugular/Subclavian Delivery System || Product Code: DL900J/DL950J; || Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
  • 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