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FDA Warns of Issue with Impella Blood Pump Controllers

News Daily News

FDA Warns of Issue with Impella Blood Pump Controllers

July 02, 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

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: No Signs of Link Between GLP-1s and Suicidal Thoughts, Actions

News Daily News

FDA: No Signs of Link Between GLP-1s and Suicidal Thoughts, Actions

January 12, 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

July 27, 2023

FDA Alert: Possible Early Deterioration of Abbott Trifecta SAVR Valves

News Daily News

FDA Alert: Possible Early Deterioration of Abbott Trifecta SAVR Valves

February 27, 2023

Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

News Daily News

Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

April 26, 2022

Fluid Leaks Spark Recall of Cardiosave Hybrid, Rescue IABPs

News Daily News

Fluid Leaks Spark Recall of Cardiosave Hybrid, Rescue IABPs

December 22, 2021

FDA: Class I Recall for Seven Models of Medtronic ICDs and CRT-Ds

News Daily News

FDA: Class I Recall for Seven Models of Medtronic ICDs and CRT-Ds

Yael L. Maxwell

April 12, 2021

Kawasaki Link to COVID-19 in Kids Probed as UK, New York Issue Alerts

News Daily News

Kawasaki Link to COVID-19 in Kids Probed as UK, New York Issue Alerts

May 06, 2020

Burst Balloons With Sapien 3 Ultra Prompt ‘Urgent Field Safety Notice’ and Canadian Recall

News Daily News

Burst Balloons With Sapien 3 Ultra Prompt ‘Urgent Field Safety Notice’ and Canadian Recall

July 22, 2019

Terumo’s Solopath Transfemoral System and Recollapsible Balloon Access System Recalled for Dislodging Issues

News Daily News

Terumo’s Solopath Transfemoral System and Recollapsible Balloon Access System Recalled for Dislodging Issues

May 30, 2019

FDA Tallies Cases of Fournier Gangrene in Patients Taking SGLT2 Inhibitors

News Daily News

FDA Tallies Cases of Fournier Gangrene in Patients Taking SGLT2 Inhibitors

Michael O'Riordan

May 08, 2019

FDA Warns of Stroke and Arterial Dissection Risk With MS Drug

News Daily News

FDA Warns of Stroke and Arterial Dissection Risk With MS Drug

November 29, 2018

FDA Touts Increased Oversight of Medical Device Makers

News Daily News

FDA Touts Increased Oversight of Medical Device Makers

Michael O'Riordan

November 22, 2018

FDA: All AFX Endovascular AAA Systems Now Under Class I Recall

News Daily News

FDA: All AFX Endovascular AAA Systems Now Under Class I Recall

October 16, 2018

Catheter Kerfuffle: How Concerning Is Off-Label Use in Stroke Interventions?

News Features

Catheter Kerfuffle: How Concerning Is Off-Label Use in Stroke Interventions?

June 21, 2017

News Daily News

HeartMate II Left Ventricular Assist System Under Recall Due to Controller Exchange Problems

May 24, 2017

News Daily News

Wingman35 Crossing Catheters Recalled Due to Tip Splitting, Separation

May 04, 2017

News Daily News

Boston Scientific Announces Fix for Lotus Edge TAVR Device Following Implantation ‘Pause’

January 11, 2017

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