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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

Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

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Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

August 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

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

Class I Recall of Batteries for Cardiosave Hybrid/Rescue IABPs: FDA

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Class I Recall of Batteries for Cardiosave Hybrid/Rescue IABPs: FDA

October 29, 2021

FDA: Class I Recall of Precise PRO Rx Carotid Stent System

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FDA: Class I Recall of Precise PRO Rx Carotid Stent System

April 23, 2021

FDA: Class I Recall for CentriMag Circulatory Support System Motor

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FDA: Class I Recall for CentriMag Circulatory Support System Motor

November 07, 2019

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

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

February 04, 2019

No More Absorb BVS: Abbott Puts a Stop to Sales

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No More Absorb BVS: Abbott Puts a Stop to Sales

September 08, 2017

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