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Displaying 1 - 20 of 28
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Medline Recalls Valve Pack Kits With Expired Cannulas
News Daily News

Medline Recalls Valve Pack Kits With Expired Cannulas

Yael L. Maxwell
Yael L. Maxwell
September 16, 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
Sanjay Kaul, MD
March 29, 2024
FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction
News Daily News

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

Caitlin E. Cox
Caitlin E. Cox
July 27, 2023
CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting
News Daily News

CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting

L.A. McKeown
L.A. McKeown
July 12, 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
FDA Alert: Possible Early Deterioration of Abbott Trifecta SAVR Valves
News Daily News

FDA Alert: Possible Early Deterioration of Abbott Trifecta SAVR Valves

Todd Neale
Todd Neale
February 27, 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
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 Safety Communication Updates Stance on Endologix AAA Grafts
News Daily News

FDA Safety Communication Updates Stance on Endologix AAA Grafts

L.A. McKeown
L.A. McKeown
January 13, 2022
FDA Reminder: Yearly, Lifelong Surveillance Needed for Endologix AAA Grafts
News Daily News

FDA Reminder: Yearly, Lifelong Surveillance Needed for Endologix AAA Grafts

L.A. McKeown
L.A. McKeown
December 04, 2020
Lotus Edge TAVR Device Recalled and Discontinued Worldwide
News Daily News

Lotus Edge TAVR Device Recalled and Discontinued Worldwide

Michael O'Riordan
Michael O'Riordan
November 18, 2020
CMS Releases Proposed Updates for Coverage of Transcatheter MV Repair
News Daily News

CMS Releases Proposed Updates for Coverage of Transcatheter MV Repair

Todd Neale
Todd Neale
July 01, 2020
FDA Class I Recall for Boston Scientific’s IMAGER II Angiographic Catheters
News Daily News

FDA Class I Recall for Boston Scientific’s IMAGER II Angiographic Catheters

L.A. McKeown
L.A. McKeown
April 07, 2020
FDA: Abbott Recalls NC Trek RX and NC Traveler Coronary Catheters
News Daily News

FDA: Abbott Recalls NC Trek RX and NC Traveler Coronary Catheters

Shelley Wood
Shelley Wood
February 24, 2020
European Regulators Approve First Transcatheter MV Replacement Device
News Daily News

European Regulators Approve First Transcatheter MV Replacement Device

Michael O'Riordan
Michael O'Riordan
January 30, 2020
FDA: Class I Recall for CentriMag Circulatory Support System Motor
News Daily News

FDA: Class I Recall for CentriMag Circulatory Support System Motor

Caitlin E. Cox
Caitlin E. Cox
November 07, 2019
FDA: New Concerns Surface With Endologix Grafts for AAA
News Daily News

FDA: New Concerns Surface With Endologix Grafts for AAA

L.A. McKeown
L.A. McKeown
October 28, 2019
FDA: Class I Recall for Burst Balloons With Sapien 3 Ultra Delivery System
News Daily News

FDA: Class I Recall for Burst Balloons With Sapien 3 Ultra Delivery System

Michael O'Riordan
Michael O'Riordan
August 22, 2019
FDA Expands TAVR Indication to Low-Risk Patients
News Daily News

FDA Expands TAVR Indication to Low-Risk Patients

Michael O'Riordan
Michael O'Riordan
August 16, 2019

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