Z-1149-2013Class II

MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0)

Name: Z-1149-2013 MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0)
Creator: Maquet Cardiovascular, LLC
Published: 2013-03-07
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2013-03-07 / Terminated / root cause: software

FDA source

Maquet Cardiovascular, LLC began a recall of 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... on 2013-03-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1149-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-07
Posted: 2013-04-18
Terminated: 2013-08-22
Recalling firm: Maquet Cardiovascular LLC
Product: 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 code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
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
Root cause tag: software
FDA root cause: Software change control
Action: MAQUET sent an Urgent Medical Device Field Correction letters dated March 7, 2013 via Federal Express to all affected customers. The letter identifies the affected product, problem and actions to be taken. Customers are asked to complete and submit the included Customer Fax-back Form. Maquet Service will exchange all affected products with the updated version. For questions MAQUET Customer Service at 888-627-8383 (press option 2, followed by option 2).
Quantity in commerce: 154 units affected
Distribution: 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.
Product codes and lots: Catalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1149-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1149-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-18

Product code DTQ

K102726Class IICardiohelp SystemMaquet Cardiopulmonary, AG / cleared 2011-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)