Maquet Cardiovascular, LLC: Medical Device Recall in 2013 - (Recall #: Z-1149-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: March 7, 2013

Date Posted: April 24, 2013

Recall Number: Z-1149-2013

Event ID: 64641

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

Status: Terminated

Product Quantity: 154 units affected

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated