Class II — Potential Health Hazard

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

Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive Recalled by Maquet Cardiovascular Us Sales, Llc Due to A loose ODU plug / Coaxial cable connection...

Date: December 3, 2019
Company: Maquet Cardiovascular Us Sales, Llc
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 Maquet Cardiovascular Us Sales, Llc directly.

Affected Products

Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

Quantity: 11 distributed in the US

Why Was This Recalled?

A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.

Where Was This Sold?

This product was distributed to 7 states: ME, NV, NY, OH, PA, TX, VA

Affected (7 states)Not affected

About Maquet Cardiovascular Us Sales, Llc

Maquet Cardiovascular Us Sales, Llc has 62 total recalls tracked by RecallDetector.

Related Recalls

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