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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

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

News Daily News

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

March 21, 2024

European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba

News Daily News

European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba

Michael O'Riordan

September 15, 2023

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

Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

News Daily News

Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

July 26, 2023

Class I Recall for 350,000 Medtronic Defibrillators: FDA

News Daily News

Class I Recall for 350,000 Medtronic Defibrillators: FDA

Michael O'Riordan

July 19, 2023

Generic Dabigatran Lots Pulled for Nitrosamine Impurity

News Daily News

Generic Dabigatran Lots Pulled for Nitrosamine Impurity

Michael O'Riordan

March 28, 2023

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

News Daily News

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

January 25, 2023

Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

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Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

May 26, 2022

Fluid Leaks Spark Recall of Cardiosave Hybrid, Rescue IABPs

News Daily News

Fluid Leaks Spark Recall of Cardiosave Hybrid, Rescue IABPs

December 22, 2021

FDA: Class I Recall of Precise PRO Rx Carotid Stent System

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FDA: Class I Recall of Precise PRO Rx Carotid Stent System

April 23, 2021

FDA: Class I Recall for HeartWare VAD Pump Implant Kit

News Daily News

FDA: Class I Recall for HeartWare VAD Pump Implant Kit

March 01, 2021

FDA Reminder: Yearly, Lifelong Surveillance Needed for Endologix AAA Grafts

News Daily News

FDA Reminder: Yearly, Lifelong Surveillance Needed for Endologix AAA Grafts

December 04, 2020

FDA Class I Recall for PTA Catheters Due to Unexpected Balloon Bursting

News Daily News

FDA Class I Recall for PTA Catheters Due to Unexpected Balloon Bursting

Yael L. Maxwell

June 18, 2019

TCTMD’s Top 10 Most Popular Stories for May 2019

News Opinion Editor's Corner

TCTMD’s Top 10 Most Popular Stories for May 2019

May 31, 2019

FDA Provides Update on Tainted ARB Investigation, With New Impurity Found

News Daily News

FDA Provides Update on Tainted ARB Investigation, With New Impurity Found

March 04, 2019

INR Test Strips Recalled Due to Inaccurate Measurements

News Daily News

INR Test Strips Recalled Due to Inaccurate Measurements

November 02, 2018

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

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