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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 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

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

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

August 18, 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

FDA: Medtronic Stops Production and Distribution of Troubled HeartWare VAD

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FDA: Medtronic Stops Production and Distribution of Troubled HeartWare VAD

June 03, 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

Class I Recall for Medtronic’s HeartWare HVAD System

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Class I Recall for Medtronic’s HeartWare HVAD System

Michael O'Riordan

June 04, 2018

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HeartMate 3 Problem With Outflow Graft Twisting Called Class I Recall by FDA

May 23, 2018

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HeartMate II Left Ventricular Assist System Under Recall Due to Controller Exchange Problems

May 24, 2017

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