CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Reported: December 13, 2023 Initiated: October 10, 2023 #Z-0420-2024
Product Description
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Reason for Recall
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.
Details
- Recalling Firm
- Maquet Medical Systems USA
- Units Affected
- Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S.
- Distribution
- 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
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.. Recalled by Maquet Medical Systems USA. Units affected: Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2023. Severity: Critical. Recall number: Z-0420-2024.
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