FDA-Device2023-03-29Class II
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Datascope Corp.
Hazard
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
Sold states
Distribution list not yet provided.
Affected count
391 total IABPs
Manufactured in
1300 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1277-2023Don't want to check this manually?
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