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Andexanet Alfa Pulled From US Market

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Andexanet Alfa Pulled From US Market

December 22, 2025

Another Issue Shelves Some Impella Blood Pump Controllers: FDA

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Another Issue Shelves Some Impella Blood Pump Controllers: FDA

August 27, 2025

Reduced Shock Efficacy With Some Boston Scientific Defibrillation Leads

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Reduced Shock Efficacy With Some Boston Scientific Defibrillation Leads

August 06, 2025

FDA Issues Safety Communication for Some Accolade Pacemakers

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FDA Issues Safety Communication for Some Accolade Pacemakers

December 16, 2024

Device Correction Issued for HeartMate Monitor Due to Potential Pump Stoppage

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Device Correction Issued for HeartMate Monitor Due to Potential Pump Stoppage

June 28, 2024

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

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

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

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Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

March 21, 2024

Biden White House Delays Decision on Menthol Ban

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Biden White House Delays Decision on Menthol Ban

Michael O'Riordan

December 07, 2023

FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal

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FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal

October 17, 2023

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

European Regulators Investigating CV Safety of Weight-Loss Drug Mysimba

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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

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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

CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting

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CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting

July 12, 2023

FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

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FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

July 11, 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

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

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Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Michael O'Riordan

January 17, 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

A Simple Nudge Moves the Needle on Statin Prescribing

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A Simple Nudge Moves the Needle on Statin Prescribing

Michael O'Riordan

December 02, 2022

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