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FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

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FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

May 08, 2024

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

FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction

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FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction

July 27, 2023

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

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Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

March 31, 2023

FDA Alert: Possible Early Deterioration of Abbott Trifecta SAVR Valves

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FDA Alert: Possible Early Deterioration of Abbott Trifecta SAVR Valves

February 27, 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

FDA: Endologix AAA Grafts Get New Labeling That Addresses Endoleak Potential

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FDA: Endologix AAA Grafts Get New Labeling That Addresses Endoleak Potential

December 06, 2022

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

Lotus Edge TAVR Device Recalled and Discontinued Worldwide

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Lotus Edge TAVR Device Recalled and Discontinued Worldwide

Michael O'Riordan

November 18, 2020

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

FDA: Class I Recall for Cook Medical’s CrossCath Support Catheters

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FDA: Class I Recall for Cook Medical’s CrossCath Support Catheters

December 17, 2019

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

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

Michael O'Riordan

August 22, 2019

FDA Expands TAVR Indication to Low-Risk Patients

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FDA Expands TAVR Indication to Low-Risk Patients

Michael O'Riordan

August 16, 2019

Burst Balloons With Sapien 3 Ultra Prompt ‘Urgent Field Safety Notice’ and Canadian Recall

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Burst Balloons With Sapien 3 Ultra Prompt ‘Urgent Field Safety Notice’ and Canadian Recall

July 22, 2019

Terumo’s Solopath Transfemoral System and Recollapsible Balloon Access System Recalled for Dislodging Issues

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Terumo’s Solopath Transfemoral System and Recollapsible Balloon Access System Recalled for Dislodging Issues

May 30, 2019

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

August 07, 2017

TCTMD’s Top 10 Most Popular Stories for April 2017

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TCTMD’s Top 10 Most Popular Stories for April 2017

April 28, 2017

Boston Scientific Recalls All Lotus Valves, Including Lotus with Depth Guard

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Boston Scientific Recalls All Lotus Valves, Including Lotus With Depth Guard

Michael O'Riordan

February 23, 2017

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