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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

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

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

Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

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Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

July 26, 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

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

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

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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

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FDA: Class I Recall for HeartWare VAD Pump Implant Kit

March 01, 2021

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

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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

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

Yael L. Maxwell

June 18, 2019

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

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

March 04, 2019

INR Test Strips Recalled Due to Inaccurate Measurements

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INR Test Strips Recalled Due to Inaccurate Measurements

November 02, 2018

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

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

August 17, 2018

FDA: Battery, Cybersecurity Issues With ICDs and CRT-Ds Now Have Firmware Fix

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FDA: Battery, Cybersecurity Issues With ICDs and CRT-Ds Now Have Firmware Fix

April 17, 2018

Abciximab in ‘Short Supply’ Worldwide

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Abciximab in ‘Short Supply’ Worldwide

April 13, 2018

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