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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

FDA Warns of Issue with Impella Blood Pump Controllers

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FDA Warns of Issue with Impella Blood Pump Controllers

July 02, 2025

FDA Issues Early Alert About Risks of Peripheral Atherectomy Device

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FDA Issues Early Alert About Risks of Peripheral Atherectomy Device

February 07, 2025

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

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

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

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

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

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

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 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

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

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

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

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

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

Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

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Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

April 26, 2022

FDA Safety Communication Updates Stance on Endologix AAA Grafts

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FDA Safety Communication Updates Stance on Endologix AAA Grafts

January 13, 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

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