MAQUET CARDIOHELP Support System: CARDIOHELP-I Software… recallZ-1149-2013 · Maquet Cardiovascular, LLC · initiated Mar 7, 2013
Class II Terminated All recalls posted in April 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Software change control
What the company is doing
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).
Recall details
- Recall number
- Z-1149-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 7, 2013
- Posted by the FDA
- Apr 18, 2013
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 154 units affected
- Product code
- DTQ
- FDA submissions
- K102726
- 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 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).
Code information (models, lots, serial numbers)
Catalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers.
Other devices under the same FDA submission
1 device cleared under K102726 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA Wall holder HKH 8820Maquet Cardiopulmonary AG · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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