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News Daily News

Another Issue Shelves Some Impella Blood Pump Controllers: FDA

Todd Neale

August 27, 2025

News Daily News

FDA Warns of Issue with Impella Blood Pump Controllers

Todd Neale

July 02, 2025

News Daily News

FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

Todd Neale

May 08, 2024

News Opinion Off Script

Evoque and Patisiran: A Tale of Two Regulatory Journeys

Sanjay Kaul, MD

March 29, 2024

News Daily News

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

Caitlin E. Cox

March 21, 2024

News Daily News

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

Caitlin E. Cox

October 17, 2023

News Daily News

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

Caitlin E. Cox

August 18, 2023

News Daily News

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

Caitlin E. Cox

August 17, 2023

News Daily News

Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

Michael O'Riordan

August 10, 2023

News Daily News

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

Caitlin E. Cox

July 27, 2023

News Daily News

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

Caitlin E. Cox

June 05, 2023

News Daily News

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Shelley Wood

March 31, 2023

News Daily News

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Michael O'Riordan

January 17, 2023

News Daily News

Impella RP Mortality Rate No Longer a Concern, FDA Says

Caitlin E. Cox

December 05, 2022

News Daily News

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

Michael O'Riordan

October 17, 2022

News Daily News

LivaNova Recalls Some LifeSPARC Controllers Used in Advanced Circulatory Support

L.A. McKeown

September 30, 2022

News Daily News

Medtronic Recalls Batteries in Some HeartWare VAD Systems

L.A. McKeown

June 23, 2022

News Daily News

Medtronic’s HeartWare HVAD Recalled for Pump Weld Defect

L.A. McKeown

April 29, 2022

News Conference News AHA 2021

Risk-Based EHR Alert Doesn’t Improve HF Care or Outcomes: REVEAL-HF

Michael O'Riordan

November 19, 2021

News Daily News

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

Caitlin E. Cox

October 29, 2021

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Another Issue Shelves Some Impella Blood Pump Controllers: FDA

FDA Warns of Issue with Impella Blood Pump Controllers

FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

Evoque and Patisiran: A Tale of Two Regulatory Journeys

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

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

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

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

Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

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

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

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Impella RP Mortality Rate No Longer a Concern, FDA Says

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

LivaNova Recalls Some LifeSPARC Controllers Used in Advanced Circulatory Support

Medtronic Recalls Batteries in Some HeartWare VAD Systems

Medtronic’s HeartWare HVAD Recalled for Pump Weld Defect

Risk-Based EHR Alert Doesn’t Improve HF Care or Outcomes: REVEAL-HF

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

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