Original article title
Early Alert: Transcatheter Mitral Valve Delivery System Issue from Edwards Lifesciences
Source excerpt
“Potential balloon burst during inflation can lead to embolism or the need for surgery.”
Keep in mind
FDA safety alert · follow the current source instructions.
www.fda.gov
The excerpt is quoted from source text. The original title is preserved above.
This is a reading aid. Follow the source for methods, limitations, corrections, and clinical context.