Class II — Potential Health Hazard

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

Prestige Plus 185cm J-Tip: Part number: 9185J Recalled by Volcano Corporation Due to During a relabeling procedure at the manufacturing facility,...

Date: June 4, 2015
Company: Volcano Corporation
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 Volcano Corporation directly.

Affected Products

Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

Quantity: 162 total (both devices)

Why Was This Recalled?

During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Volcano Corporation

Volcano Corporation has 22 total recalls tracked by RecallDetector.

Related Recalls

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