Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2019 - (Recall #: Z-0678-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 3, 2019

Date Posted: December 18, 2019

Recall Number: Z-0678-2020

Event ID: 84377

Reason for Recall:

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

Status: Terminated

Product Quantity: 11 distributed in the US

Code Information:

UDI: 04037691258997; Serial Numbers 9348936 910114412 910114420 910114429 910114430 910114432 910114435 910114438 910117243 91064722 91067680

Distribution Pattern:

The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated