Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters. Recalled by Bard Peripheral Vascular Inc Due to IFU missing contraindications: Patients with uncontrolled sepsis and...

Date: March 13, 2015
Company: Bard Peripheral Vascular Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bard Peripheral Vascular Inc directly.

Affected Products

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

Quantity: 1,183 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About Bard Peripheral Vascular Inc

Bard Peripheral Vascular Inc has 136 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report