FDAOctober 10, 2023device
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
maquet medical systemsmaquetmaquet medical
UPCs
04037691643526
Recall history
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