Z-1069-2016Class II

Denali Filter-Femoral Delivery System

Name: Z-1069-2016 Denali Filter-Femoral Delivery System
Creator: Bard Peripheral Vascular Inc
Published: 2016-02-09
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2016-02-09 / Terminated / root cause: design

FDA source

Bard Peripheral Vascular Inc began a recall of Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the... on 2016-02-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1069-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-09
Posted: 2016-03-08
Terminated: 2016-05-13
Recalling firm: Bard Peripheral Vascular Inc
Product: 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.
Product code: DTK Filter, Intravascular, Cardiovascular
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
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 [email protected]. 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 [email protected] 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
Quantity in commerce: 3572
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1069-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1068-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08
Z-1069-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08

Product code DTK

K130366Class IIBard Denali Filter System- Femoral Delivery Kit and Jugular Delivery KitC.R. Bard, Inc. / cleared 2013-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)