Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Cardiohelp Emergency Drive Recalled by Maquet Cardiovascular Us Sales, Llc Due to Upon servicing the gearwheel in the Emergency Drive...

Date: February 8, 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

Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.

Quantity: 10

Why Was This Recalled?

Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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