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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

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 Conference News

Paclitaxel Safety Concerns Wane as Hope Emerges for Newer PAD Devices

L.A. McKeown

November 18, 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

News Daily News

Medtronic Recalls TurboHawk Plus Atherectomy System

Todd Neale

March 09, 2022

News Daily News

HawkOne Directional Atherectomy System Recalled Due to Risk of Tip Breakage

L.A. McKeown

January 21, 2022

News Daily News

Wirion Embolic Protection System Recalled Over Filter Breakage

Todd Neale

January 10, 2022

News Daily News

Penumbra’s JET 7 Recall: A Kick Start to Change?

Caitlin E. Cox

December 01, 2021

News Daily News

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

Caitlin E. Cox

October 29, 2021

News Features

Expired Cardiac Devices May Do Global Good, but Safety Unknown

Yael L. Maxwell

August 26, 2021

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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

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Paclitaxel Safety Concerns Wane as Hope Emerges for Newer PAD Devices

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

Medtronic Recalls TurboHawk Plus Atherectomy System

HawkOne Directional Atherectomy System Recalled Due to Risk of Tip Breakage

Wirion Embolic Protection System Recalled Over Filter Breakage

Penumbra’s JET 7 Recall: A Kick Start to Change?

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

Expired Cardiac Devices May Do Global Good, but Safety Unknown

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