Class II — Potential Health Hazard

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

Acrobat SUV Vacuum Stabilizer System Recalled by Maquet Cardiovascular, LLC Due to Deviations in the manufacturing process created a compromise...

Date: October 16, 2024
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

Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z

Quantity: 10,778 units

Why Was This Recalled?

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

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