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Medline Recalls Valve Pack Kits With Expired Cannulas

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Medline Recalls Valve Pack Kits With Expired Cannulas

Yael L. Maxwell

September 16, 2025

Another Issue Shelves Some Impella Blood Pump Controllers: FDA

News Daily News

Another Issue Shelves Some Impella Blood Pump Controllers: FDA

August 27, 2025

FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

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FDA Warns of Air Embolism Risk With Watchman LAAO Access Systems

August 06, 2025

Reduced Shock Efficacy With Some Boston Scientific Defibrillation Leads

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Reduced Shock Efficacy With Some Boston Scientific Defibrillation Leads

August 06, 2025

FDA Warns of Issue with Impella Blood Pump Controllers

News Daily News

FDA Warns of Issue with Impella Blood Pump Controllers

July 02, 2025

FDA Issues Early Alert About Risks of Peripheral Atherectomy Device

News Daily News

FDA Issues Early Alert About Risks of Peripheral Atherectomy Device

February 07, 2025

FDA Issues Safety Communication for Some Accolade Pacemakers

News Daily News

FDA Issues Safety Communication for Some Accolade Pacemakers

December 16, 2024

Device Correction Issued for HeartMate Monitor Due to Potential Pump Stoppage

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Device Correction Issued for HeartMate Monitor Due to Potential Pump Stoppage

June 28, 2024

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

News Daily News

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

Yael L. Maxwell

April 03, 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

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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

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

News Daily News

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

News Daily News

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

Michael O'Riordan

August 10, 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 350,000 Medtronic Defibrillators: FDA

News Daily News

Class I Recall for 350,000 Medtronic Defibrillators: FDA

Michael O'Riordan

July 19, 2023

CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting

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CMS Issues Proposed Coverage Decision to Broaden Access for Carotid Stenting

July 12, 2023

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

Abiomed Recalls Certain Impella 5.5 Devices Due to Risk of Purge-Fluid Leaks

News Daily News

Abiomed Recalls Certain Impella 5.5 Devices Due to Risk of Purge-Fluid Leaks

June 05, 2023

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