Z-0737-2016Class II

Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters

Name: Z-0737-2016 Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters
Creator: Bard Peripheral Vascular Inc
Published: 2015-03-13
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2015-03-13 / Terminated / root cause: labeling and UDI

FDA source

Bard Peripheral Vascular Inc began a recall of Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters on 2015-03-13. FDA classified it as Class II and gives the reason as "IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0737-2016
Classification: Class II
Status: Terminated
Initiated: 2015-03-13
Posted: 2016-02-01
Terminated: 2016-02-01
Recalling firm: Bard Peripheral Vascular Inc
Product: Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
Product code: DTK Filter, Intravascular, Cardiovascular
Reason for recall: IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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
Quantity in commerce: 1,183 units
Distribution: Distributed to CA only.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0737-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0737-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-01

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)