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