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FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

Todd Neale

August 06, 2025

News Conference News ACC 2025

DETECT-AS: Alert System Increases AV Replacement in Eligible Patients

Michael O'Riordan

April 04, 2025

News Daily News

Class I Recall for 330,000 Radial Artery Catheterization Kits: FDA

Yael L. Maxwell

April 03, 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

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

Caitlin E. Cox

July 27, 2023

News Daily News

Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

Shelley Wood

July 26, 2023

News Daily News

CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting

L.A. McKeown

July 12, 2023

News Daily News

FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

L.A. McKeown

July 11, 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

FDA: Endologix AAA Grafts Get New Labeling That Addresses Endoleak Potential

L.A. McKeown

December 06, 2022

News Daily News

Impella RP Mortality Rate No Longer a Concern, FDA Says

Caitlin E. Cox

December 05, 2022

News Daily News

FDA, Abbott Warn of Potential MitraClip Locking Malfunctions

L.A. McKeown

September 09, 2022

News Daily News

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

L.A. McKeown

August 19, 2022

News Daily News

Medtronic Recalls Batteries in Some HeartWare VAD Systems

L.A. McKeown

June 23, 2022

News Daily News

Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

Todd Neale

May 26, 2022

News Daily News

Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

L.A. McKeown

April 26, 2022

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FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

DETECT-AS: Alert System Increases AV Replacement in Eligible Patients

Class I Recall for 330,000 Radial Artery Catheterization Kits: FDA

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

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

Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting

FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

FDA: Endologix AAA Grafts Get New Labeling That Addresses Endoleak Potential

Impella RP Mortality Rate No Longer a Concern, FDA Says

FDA, Abbott Warn of Potential MitraClip Locking Malfunctions

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

Medtronic Recalls Batteries in Some HeartWare VAD Systems

Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

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