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Another Issue Shelves Some Impella Blood Pump Controllers: FDA

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Another Issue Shelves Some Impella Blood Pump Controllers: FDA

August 27, 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

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

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Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

March 21, 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

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

Abiomed Recalls Certain Impella 5.5 Devices Due to Risk of Purge-Fluid Leaks

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Abiomed Recalls Certain Impella 5.5 Devices Due to Risk of Purge-Fluid Leaks

June 05, 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 Provides Update on Poorer Survival With Impella RP in Postmarket Setting

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FDA Provides Update on Poorer Survival With Impella RP in Postmarket Setting

May 21, 2019

FDA Warns Healthcare Providers of Potential Rise in Death Rate With Impella RP

News Daily News

FDA Warns Healthcare Providers of Potential Rise in Death Rate With Impella RP

February 04, 2019

TCTMD’s Top 10 Most Popular Stories for October 2017

News Opinion Editor's Corner

TCTMD’s Top 10 Most Popular Stories for October 2017

October 29, 2017

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