Class II — Potential Health Hazard

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

Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Recalled by C.R. Bard, Inc. Due to Labeling: Statement was added to the Warnings/Precautions section...

Date: October 13, 2016
Company: C.R. Bard, 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 C.R. Bard, Inc. directly.

Affected Products

Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

Quantity: 75,089 units

Why Was This Recalled?

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About C.R. Bard, Inc.

C.R. Bard, Inc. has 51 total recalls tracked by RecallDetector.

Related Recalls

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