Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump Recalled by Maquet Datascope Corp - Cardiac Assist Division Due to Ferrule Cap was not removed on some fiber-optic...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Datascope Corp - Cardiac Assist Division directly.
Affected Products
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.
Quantity: 838 units-US; 364 units - OUS
Why Was This Recalled?
Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.
Where Was This Sold?
Worldwide Distribution
About Maquet Datascope Corp - Cardiac Assist Division
Maquet Datascope Corp - Cardiac Assist Division has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report