Bard Peripheral Vascular Inc: Medical Device Recall in 2016 - (Recall #: Z-0737-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: March 13, 2015
Date Posted: February 10, 2016
Recall Number: Z-0737-2016
Event ID: 72945
Reason for Recall:

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

Status: Terminated
Product Quantity: 1,183 units
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.

Voluntary or Mandated:

Voluntary: Firm initiated