CLASS II Device recall · Reported 24 Apr 2013 · FDA Enforcement Report

Maquet Cardiohelp Support System: Cardiohelp-i recalled

Maquet Cardiovascular is recalling Maquet Cardiohelp Support System: Cardiohelp-i, distributed nationwide in the US. The recall was initiated on 7 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers.

Quantity recalled154 units affected

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-1149-2013
FDA event ID: 64641
Recalling firm: Maquet Cardiovascular, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 7 Mar 2013
FDA classified: 18 Apr 2013
Reported: 24 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

7 Mar 2013	Recall initiated by company
18 Apr 2013	Classified by FDA	+42 days
24 Apr 2013	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

It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARDIOHELP device, where measured values, settings and alarms are displayed and adjusted/confirmed, with the exception of bl

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

Where it was distributed

Worldwide Distribution - USA Nationwide and the following countries: Australia, Austria, Belarus, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Iceland, Iran, Ireland, Italy, Jordan, Kazakhstan, Korea, Kuwait, Luxembourg, The Netherlands, Norway, Oman, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and the United Kingdom.

Nationwide

Questions about this recall

Is Maquet Cardiohelp Support System: Cardiohelp-i recalled?

Yes. Maquet Cardiovascular recalled Maquet Cardiohelp Support System: Cardiohelp-i on 7 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1149-2013.

Why was it recalled?

Which lots are affected?

Catalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers.

Where was it sold?

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 21 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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