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Another Issue Shelves Some Impella Blood Pump Controllers: FDA

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Another Issue Shelves Some Impella Blood Pump Controllers: FDA

August 27, 2025

FDA Warns of Issue with Impella Blood Pump Controllers

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FDA Warns of Issue with Impella Blood Pump Controllers

July 02, 2025

Eye Condition a ‘Very Rare’ Side Effect of Semaglutide, EMA Says

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Eye Condition a ‘Very Rare’ Side Effect of Semaglutide, EMA Says

June 06, 2025

FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

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FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

May 08, 2024

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

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

Yael L. Maxwell

April 03, 2024

Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

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Cardiosave IABPs—Yet Again—the Subject of a Class I Recall: FDA

August 17, 2023

Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

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Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

Michael O'Riordan

August 10, 2023

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

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Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

March 31, 2023

Generic Dabigatran Lots Pulled for Nitrosamine Impurity

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Generic Dabigatran Lots Pulled for Nitrosamine Impurity

Michael O'Riordan

March 28, 2023

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

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Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Michael O'Riordan

January 17, 2023

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

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

December 06, 2022

Medtronic Recalls TurboHawk Plus Atherectomy System

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Medtronic Recalls TurboHawk Plus Atherectomy System

March 09, 2022

Wirion Embolic Protection System Recalled Over Filter Breakage

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Wirion Embolic Protection System Recalled Over Filter Breakage

January 10, 2022

Papers Probe Temporal Link Between COVID-19 Vaccines and Myocarditis

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Papers Probe Temporal Link Between COVID-19 Vaccines and Myocarditis

Michael O'Riordan

June 17, 2021

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

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

February 24, 2020

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

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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

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FDA Tallies Cases of Fournier Gangrene in Patients Taking SGLT2 Inhibitors

Michael O'Riordan

May 08, 2019

Two Pediatric Cardiac Catheters Recalled for Defective Balloons

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Two Pediatric Cardiac Catheters Recalled for Defective Balloons

April 26, 2019

FDA Analysis Points to Higher Death Risk With Paclitaxel-Based Devices for PAD

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FDA Analysis Points to Higher Death Risk With Paclitaxel-Based Devices for PAD

March 15, 2019

Class I Recall for Certain Medtronic Pacemakers Due to Possible Circuit Error

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Class I Recall for Certain Medtronic Pacemakers Due to Possible Circuit Error

February 15, 2019

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