CLASS II Device recall · Reported 18 Dec 2019 · FDA Enforcement Report

Maquet Cardiopulmonary (MCP)/Getinge Rotaflow Drive recalled

Maquet Cardiovascular Us Sales is recalling Maquet Cardiopulmonary (MCP)/Getinge Rotaflow Drive, distributed in 7 states. The recall was initiated on 3 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 04037691258997; Serial Numbers 9348936 910114412 910114420 910114429 910114430 910114432 910114435 910114438 910117243 91064722 91067680

Quantity recalled11 distributed in the US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0678-2020
FDA event ID: 84377
Recalling firm: Maquet Cardiovascular Us Sales, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 3 Dec 2019
FDA classified: 12 Dec 2019
Reported: 18 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Dec 2019	Recall initiated by company
12 Dec 2019	Classified by FDA	+9 days
18 Dec 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Maine Nevada New York Ohio Pennsylvania Texas Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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