FDA Device recall Z-0737-2016
Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters
- FDA Device
- Class II
- terminated
- Published 2016-02-10
On 2016-02-10 the FDA classified a Class II recall of Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters by Bard Peripheral Vascular, citing IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0737-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-13 |
| Published | 2016-02-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | CA |
Product
Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
Reason
IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
Identifiers
| code_info | Product Code: DL950J Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699 Pro…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0737-2016%22
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