April 30, 2019
FDA: Class I recall of Miller and Fogarty Atrioseptostomy Dilation Catheters
Editor's Note
The Food & Drug Administration (FDA) on April 26 identified the recall of Edwards Lifesciences' Miller and Fogarty Atrioseptostomy Dilation Catheters as Class I, the most serious.
The recall was initiated because of reports of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment on retrieval.
The catheters are used to enlarge the opening between the two upper chambers (atria) of the heart.
Free Daily News
- Study: COVID-19's impact on oncological surgery offers lessons for future crises
- Study links pandemic stress to persistent increases in nursing-sensitive quality indicators
- Save the date for the 2025 OR Business Management Conference
- Study: Education, exercise improve knee OA with or without prior surgery
- Study: Early surgery outperforms endoscopy for long-term pancreatitis
- Study: Blood thinner, NSAID combination raises bleeding risk
- Hospital financial report predicts stability, high cybersecurity costs for 2025
- IV fluid shortage drives innovation in hospital hydration practices
- FDA Class 1 recalls target anesthesia workstations, ambulatory infusion pumps, ventilators
- Five leadership lessons from an ASC CEO
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement