Events

Recall of Device Recall Denali Filter Femoral 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-1069-2016
  • 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=143978
  • 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 Filter Femoral Delivery System
  • Model / Serial
    Product # Lot # DL900F GFZJ0276 DL900F GFZJ0278 DL900F GFZJ0277 DL900F GFZJ0279 DL900F GFZJ0421 DL900F GFZJ0425 DL900F GFZJ0430 DL900F GFZJ0432 DL900F GFZJ0429 DL950F GFZJ0223 DL900F GFZJ0433 DL900F GFZJ0434 DL950F GFZJ1174 DL900F GFZJ0436 DL900F GFZJ0435 DL900F GFZJ0442 DL900F GFZJ0443 DL900F GFZK0287 DL900F GFZJ0446 DL900F GFZK0291 DL900F GFZK0288 DL900F GFZJ0444 DL900F GFZK0290 DL900F GFZK0289 DL900F GFZK0292 DL900F GFZK0294 DL900F GFZK0296 DL900F GFZK0293 DL900F GFZK0294 DL900F GFZK0297 DL900F GFZK0295 DL900F GFZK0299 DL900F GFZK0298 DL900F GFZK0300 DL900F GFZK0301 DL900F GFZK0302 DL900F GFZK0351 DL900F GFZK0352 DL900F GFZK0356 DL900F GFZK0355 DL900F GFZK0357 DL900F GFZK0337 DL900F GFZK0354 DL900F GFZK0338 DL900F GFZK0364 DL900F GFZK0339 DL950F GFZK2368 DL900F GFZK3526 DL900F GFZK0367 DL900F GFZK3527 DL900F GFZK3524 DL900F GFZK3525 DL900F GFZK0328 DL900F GFZK0330 DL900F GFZK0331 DL900F GFZK0332 DL900F GFZK0333 DL900F GFZK0334 DL900F GFZK3523 DL900F GFZK0336 DL900F GFZK0335 DL900F GFZK3528 DL900F GFZK3529 DL900F GFZK3530 DL900F GFZK3538 DL900F GFZK3543 DL950F GFZK2369
  • 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-Femoral Delivery System || Product Code: DL900F/DL950F; || 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