Reported Apr 24, 2013 · Terminated
MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is…
Maquet Cardiovascular, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- MAQUET CARDIOHELP Support SystemCARDIOHELP-I Software (up to version 3.3.0.0)
- Product UsageThe 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)
- Lot codes and dates
- Catalog Number70104.8012 Cardiohelp-i. Multiple serial numbers
- Amount recalled
- 154 units affected
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
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