FDA-Device2018-11-07Class I

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

Maquet Datascope Corp - Cardiac Assist Division
Hazard

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

Sold states
US Nationwide; Internationally to 77 countries
Affected count
N/A
Manufactured in
1300 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0099-2019

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