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FDA Issues Early Alert About Risks of Peripheral Atherectomy Device

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FDA Issues Early Alert About Risks of Peripheral Atherectomy Device

February 07, 2025

FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

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FDA: All Restrictions on Paclitaxel Devices for PAD Are Removed

July 11, 2023

Medtronic Recalls TurboHawk Plus Atherectomy System

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Medtronic Recalls TurboHawk Plus Atherectomy System

March 09, 2022

HawkOne Directional Atherectomy System Recalled Due to Risk of Tip Breakage

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HawkOne Directional Atherectomy System Recalled Due to Risk of Tip Breakage

January 21, 2022

FDA Class I Recall for PTA Catheters Due to Unexpected Balloon Bursting

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FDA Class I Recall for PTA Catheters Due to Unexpected Balloon Bursting

Yael L. Maxwell

June 18, 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

Mortality Data ‘Inadvertently Omitted’ From IN.PACT Analysis of Paclitaxel-Coated Balloons

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Mortality Data ‘Inadvertently Omitted’ From IN.PACT Analysis of Paclitaxel-Coated Balloons

February 19, 2019

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Wingman35 Crossing Catheters Recalled Due to Tip Splitting, Separation

May 04, 2017

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