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FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

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FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

August 06, 2025

Class I Recall for 330,000 Radial Artery Catheterization Kits: FDA

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Class I Recall for 330,000 Radial Artery Catheterization Kits: FDA

Yael L. Maxwell

April 03, 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

FDA: No Signs of Link Between GLP-1s and Suicidal Thoughts, Actions

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FDA: No Signs of Link Between GLP-1s and Suicidal Thoughts, Actions

January 12, 2024

GLP-1 Meds Linked to 265 Reports to FDA of Suicidal Ideation: Reuters

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GLP-1 Meds Linked to 265 Reports to FDA of Suicidal Ideation: Reuters

September 28, 2023

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

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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

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

Michael O'Riordan

August 10, 2023

Class I Recall for 350,000 Medtronic Defibrillators: FDA

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Class I Recall for 350,000 Medtronic Defibrillators: FDA

Michael O'Riordan

July 19, 2023

Generic Dabigatran Lots Pulled for Nitrosamine Impurity

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Generic Dabigatran Lots Pulled for Nitrosamine Impurity

Michael O'Riordan

March 28, 2023

Impella RP Mortality Rate No Longer a Concern, FDA Says

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Impella RP Mortality Rate No Longer a Concern, FDA Says

December 05, 2022

FDA, Abbott Warn of Potential MitraClip Locking Malfunctions

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FDA, Abbott Warn of Potential MitraClip Locking Malfunctions

September 09, 2022

Medtronic Recalls Batteries in Some HeartWare VAD Systems

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Medtronic Recalls Batteries in Some HeartWare VAD Systems

June 23, 2022

Medtronic’s HeartWare HVAD Recalled for Pump Weld Defect

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Medtronic’s HeartWare HVAD Recalled for Pump Weld Defect

April 29, 2022

Wirion Embolic Protection System Recalled Over Filter Breakage

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Wirion Embolic Protection System Recalled Over Filter Breakage

January 10, 2022

FDA Investigating Possible Sex Differences in LAAO Outcomes

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FDA Investigating Possible Sex Differences in LAAO Outcomes

September 27, 2021

Class I Recall for Cordis’ Super Torque Catheters with Radiopaque Markers

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Class I Recall for Cordis’ Super Torque Catheters with Radiopaque Markers

Michael O'Riordan

September 23, 2021

Uptick in ‘Implausible’ Cancers Reported After ARB Recalls

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Uptick in ‘Implausible’ Cancers Reported After ARB Recalls

August 20, 2021

Medtronic Vascular Recalls Angiographic Guidewire Components

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Medtronic Vascular Recalls Angiographic Guidewire Components

July 02, 2021

FDA: Medtronic Stops Production and Distribution of Troubled HeartWare VAD

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FDA: Medtronic Stops Production and Distribution of Troubled HeartWare VAD

June 03, 2021

TCTMD’s Top 10 Most Popular Stories for April 2021

News Opinion Editor's Corner

TCTMD’s Top 10 Most Popular Stories for April 2021

May 03, 2021

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