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FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

News Daily News

FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

August 06, 2025

FDA Warns of Issue with Impella Blood Pump Controllers

News Daily News

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

News Daily News

Device Correction Issued for HeartMate Monitor Due to Potential Pump Stoppage

June 28, 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

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

News Daily News

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

March 21, 2024

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

News Daily News

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

News Daily News

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

News Daily News

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

News Daily News

FDA Alert: Possible Early Deterioration of Abbott Trifecta SAVR Valves

February 27, 2023

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

News Daily News

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

December 06, 2022

A Simple Nudge Moves the Needle on Statin Prescribing

News Daily News

A Simple Nudge Moves the Needle on Statin Prescribing

Michael O'Riordan

December 02, 2022

FDA, Abbott Warn of Potential MitraClip Locking Malfunctions

News Daily News

FDA, Abbott Warn of Potential MitraClip Locking Malfunctions

September 09, 2022

Medtronic Recalls Batteries in Some HeartWare VAD Systems

News Daily News

Medtronic Recalls Batteries in Some HeartWare VAD Systems

June 23, 2022

Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

News Daily News

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

News Daily News

Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

April 26, 2022

FDA Safety Communication Updates Stance on Endologix AAA Grafts

News Daily News

FDA Safety Communication Updates Stance on Endologix AAA Grafts

January 13, 2022

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