Class II — Potential Health Hazard

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

Hemopro 2 with Vasoshield Recalled by Maquet Cardiovascular, LLC Due to Foreign Object Contamination

Date: December 22, 2022
Company: Maquet Cardiovascular, LLC
Status: Ongoing
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 Maquet Cardiovascular, LLC directly.

Affected Products

Hemopro 2 with Vasoshield, Model VH-4001

Quantity: 9817 devices

Why Was This Recalled?

Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Maquet Cardiovascular, LLC

Maquet Cardiovascular, LLC has 251 total recalls tracked by RecallDetector.

Related Recalls

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