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Recall Observatory FDA recall evidence

Device product

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

Z-0737-2016

March 13, 2015

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 72945
Status
Terminated
Classification
Class II
Quantity
1,183 units
Official record key
device-enforcement:Z-0737-2016

Official wording

Reason: IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.

Code information: 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

Distribution pattern: Distributed to CA only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.