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April 04, 2025

News Daily News

FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

Todd Neale

May 08, 2024

News Daily News

Class I Recall for 330,000 Radial Artery Catheterization Kits: FDA

Yael L. Maxwell

April 03, 2024

News Daily News

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

March 21, 2024

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

October 17, 2023

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Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA

August 18, 2023

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

July 27, 2023

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Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

Shelley Wood

July 26, 2023

News Daily News

Class I Recall for 350,000 Medtronic Defibrillators: FDA

July 19, 2023

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CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting

July 12, 2023

News Daily News

FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

July 11, 2023

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

December 06, 2022

News Daily News

Impella RP Mortality Rate No Longer a Concern, FDA Says

December 05, 2022

News Daily News

A Simple Nudge Moves the Needle on Statin Prescribing

December 02, 2022

News Daily News

FDA: New Fix Available for Medtronic’s Troubled HeartWare VADs

October 17, 2022

News Daily News

LivaNova Recalls Some LifeSPARC Controllers Used in Advanced Circulatory Support

September 30, 2022

News Daily News

FDA, Abbott Warn of Potential MitraClip Locking Malfunctions

September 09, 2022

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Medtronic’s HeartWare HVAD Recalled for Pump Weld Defect

April 29, 2022

News Daily News

FDA Safety Communication Updates Stance on Endologix AAA Grafts