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Displaying 1 - 20 of 53
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FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems
News Daily News

FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

Todd Neale
Todd Neale
August 06, 2025
Reduced Shock Efficacy With Some Boston Scientific Defibrillation Leads
News Daily News

Reduced Shock Efficacy With Some Boston Scientific Defibrillation Leads

Todd Neale
Todd Neale
August 06, 2025
FDA Issues Safety Communication for Some Accolade Pacemakers
News Daily News

FDA Issues Safety Communication for Some Accolade Pacemakers

L.A. McKeown
L.A. McKeown
December 16, 2024
Device Correction Issued for HeartMate Monitor Due to Potential Pump Stoppage
News Daily News

Device Correction Issued for HeartMate Monitor Due to Potential Pump Stoppage

Todd Neale
Todd Neale
June 28, 2024
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
Sanjay Kaul, MD
March 29, 2024
FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal
News Daily News

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

Caitlin E. Cox
Caitlin E. Cox
October 17, 2023
Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA
News Daily News

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

Caitlin E. Cox
Caitlin E. Cox
August 18, 2023
Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA
News Daily News

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

Michael O'Riordan
Michael O'Riordan
August 10, 2023
Abiomed Recalls Certain Impella 5.5 Devices Due to Risk of Purge-Fluid Leaks
News Daily News

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

Caitlin E. Cox
Caitlin E. Cox
June 05, 2023
Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs
News Daily News

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Shelley Wood
Shelley Wood
March 31, 2023
New IABP Recall: Balloon Catheter Damage Might Cause Bleeding Into Pump
News Daily News

New IABP Recall: Balloon Catheter Damage Might Cause Bleeding Into Pump

Shelley Wood
Shelley Wood
January 25, 2023
Medical Devices Cleared on Faulty Predicates More Likely to be Recalled
News Daily News

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Michael O'Riordan
Michael O'Riordan
January 17, 2023
Impella RP Mortality Rate No Longer a Concern, FDA Says
News Daily News

Impella RP Mortality Rate No Longer a Concern, FDA Says

Caitlin E. Cox
Caitlin E. Cox
December 05, 2022
A Simple Nudge Moves the Needle on Statin Prescribing
News Daily News

A Simple Nudge Moves the Needle on Statin Prescribing

Michael O'Riordan
Michael O'Riordan
December 02, 2022
FDA: New Fix Available for Medtronic’s Troubled HeartWare VADs
News Daily News

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

Michael O'Riordan
Michael O'Riordan
October 17, 2022
LivaNova Recalls Some LifeSPARC Controllers Used in Advanced Circulatory Support
News Daily News

LivaNova Recalls Some LifeSPARC Controllers Used in Advanced Circulatory Support

L.A. McKeown
L.A. McKeown
September 30, 2022
FDA: Class I Recall of Cobalt and Crome ICDs and CRT-Ds Due to Reduced-Energy Shock
News Daily News

FDA: Class I Recall of Cobalt and Crome ICDs and CRT-Ds Due to Reduced-Energy Shock

L.A. McKeown
L.A. McKeown
August 19, 2022
Medtronic Recalls Batteries in Some HeartWare VAD Systems
News Daily News

Medtronic Recalls Batteries in Some HeartWare VAD Systems

L.A. McKeown
L.A. McKeown
June 23, 2022
DELIVER Trial Scores a Win for Dapagliflozin in HFpEF
News Daily News

DELIVER Trial Scores a Win for Dapagliflozin in HFpEF

L.A. McKeown
L.A. McKeown
May 05, 2022
Medtronic’s HeartWare HVAD Recalled for Pump Weld Defect
News Daily News

Medtronic’s HeartWare HVAD Recalled for Pump Weld Defect

L.A. McKeown
L.A. McKeown
April 29, 2022

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