June 7, 2018
FDA issues Class I Recall of CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope
Editor's Note
The Food & Drug Administration on June 6 identified the recall by Maquet Datascope Corp of its CARDIOSAVE Hybrid Intra-aortic Balloon Pump as Class I, the most serious.
The recall was initiated because of a design issue that allows fluid to seep into the device, which can lead to device malfunction and serious adverse health consequences, including death.
Manufacturing dates were December 12, 2011 to April 25, 2018. Distribution dates were March 6, 2012 to April 26, 2018.
Free Daily News
- AI outperforms experts in ovarian cancer ultrasound detection
- AI shows promise for addressing nursing workforce challenges
- Union nurses rally for greater staff, patient protection amid AI rollout
- OR Business Management Conference 2025: Groundbreaking opportunity for ASC leaders
- AAAHC earns CMS Medicare deemed status renewal, ensuring quality, safety in ASCs
- Trends, benchmarks, strategic insights from 2024 ASC activity
- Nurses top Gallup’s most trusted professions list as other healthcare roles decline
- Study: Adjusting Caprini score may improve perioperative VTE risk prediction for Blacks, Latinos
- HIPAA security standard update sparks debate over cost, feasibility, patient safety
- Wildfire smoke poses long-term health threats
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement