Devices

Device Recall CARDIOHELPi

Model / Serial
Catalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
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).
Manufacturer
Maquet Cardiovascular, LLC
1 Event
- Recall of Device Recall CARDIOHELPi

Manufacturer

Maquet Cardiovascular, LLC

Manufacturer Address
Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
Manufacturer Parent Company (2017)
Getinge AB
Source
USFDA

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