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

News Daily News

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

Yael L. Maxwell

April 03, 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

March 29, 2024

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

News Daily News

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

March 21, 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

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

August 18, 2023

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

July 27, 2023

Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

News Daily News

Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

July 26, 2023

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

News Daily News

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

March 31, 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

January 17, 2023

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

August 19, 2022

Medtronic Recalls Batteries in Some HeartWare VAD Systems

News Daily News

Medtronic Recalls Batteries in Some HeartWare VAD Systems

June 23, 2022

Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

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Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

May 26, 2022

Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

News Daily News

Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

April 26, 2022

Medtronic Recalls TurboHawk Plus Atherectomy System

News Daily News

Medtronic Recalls TurboHawk Plus Atherectomy System

March 09, 2022

HawkOne Directional Atherectomy System Recalled Due to Risk of Tip Breakage

News Daily News

HawkOne Directional Atherectomy System Recalled Due to Risk of Tip Breakage

January 21, 2022

Wirion Embolic Protection System Recalled Over Filter Breakage

News Daily News

Wirion Embolic Protection System Recalled Over Filter Breakage

January 10, 2022

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

News Daily News

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

December 01, 2021

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

News Daily News

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

October 29, 2021

Medtronic Vascular Recalls Angiographic Guidewire Components

News Daily News

Medtronic Vascular Recalls Angiographic Guidewire Components

July 02, 2021

TCTMD’s Top 10 Most Popular Stories for April 2021

News Opinion Editor's Corner

TCTMD’s Top 10 Most Popular Stories for April 2021

May 03, 2021

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