CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.
US Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC, FL, HI, IA, IL, IN, KY, MD, MI, MN, MO, NE, OH, SC, VA Foreign distribution to: Austria, Australia, Brazil, Canada, Chile, China, Czech Republic, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Jordan, Mexico, New Zealand, Pakistan, Portugal, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0420-2024