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FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

News Daily News

FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

August 06, 2025

FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

News Daily News

FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

May 08, 2024

Evoque and Patisiran: A Tale of Two Regulatory Journeys

News Opinion Off Script

Evoque and Patisiran: A Tale of Two Regulatory Journeys

Sanjay Kaul, MD

March 29, 2024

Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

News Daily News

Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

August 17, 2023

Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

News Daily News

Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

Michael O'Riordan

August 10, 2023

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

News Daily News

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

March 31, 2023

New IABP Recall: Balloon Catheter Damage Might Cause Bleeding Into Pump

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New IABP Recall: Balloon Catheter Damage Might Cause Bleeding Into Pump

January 25, 2023

LivaNova Recalls Some LifeSPARC Controllers Used in Advanced Circulatory Support

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LivaNova Recalls Some LifeSPARC Controllers Used in Advanced Circulatory Support

September 30, 2022

Fluid Leaks Spark Recall of Cardiosave Hybrid, Rescue IABPs

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Fluid Leaks Spark Recall of Cardiosave Hybrid, Rescue IABPs

December 22, 2021

CMS Releases Proposed Updates for Coverage of Transcatheter MV Repair

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CMS Releases Proposed Updates for Coverage of Transcatheter MV Repair

July 01, 2020

European Regulators Approve First Transcatheter MV Replacement Device

News Daily News

European Regulators Approve First Transcatheter MV Replacement Device

Michael O'Riordan

January 30, 2020

FDA: Class I Recall for Burst Balloons With Sapien 3 Ultra Delivery System

News Daily News

FDA: Class I Recall for Burst Balloons With Sapien 3 Ultra Delivery System

Michael O'Riordan

August 22, 2019

FDA Warns of Deaths, Stroke With Latest-Generation Total Artificial Heart

News Daily News

FDA Warns of Deaths, Stroke Due to Power System Problems With Total Artificial Heart System

August 17, 2018

News Daily News

FDA Deems ‘Field Action’ for Faulty IABPs a Class I Recall

August 07, 2017

TCTMD’s Top 10 Most Popular Stories for May 2017

News Opinion Editor's Corner

TCTMD’s Top 10 Most Popular Stories for May 2017

June 01, 2017

News Daily News

Boston Scientific Announces Fix for Lotus Edge TAVR Device Following Implantation ‘Pause’

January 11, 2017

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