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News Daily News

Medline Recalls Valve Pack Kits With Expired Cannulas

Yael L. Maxwell

September 16, 2025

News Daily News

FDA Issues Safety Communication for Some Accolade Pacemakers

L.A. McKeown

December 16, 2024

News Daily News

Device Correction Issued for HeartMate Monitor Due to Potential Pump Stoppage

Todd Neale

June 28, 2024

News Daily News

FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

Todd Neale

May 08, 2024

News Daily News

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

Yael L. Maxwell

April 03, 2024

News Opinion Off Script

Evoque and Patisiran: A Tale of Two Regulatory Journeys

Sanjay Kaul, MD

March 29, 2024

News Daily News

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

Caitlin E. Cox

March 21, 2024

News Daily News

FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal

Caitlin E. Cox

October 17, 2023

News Daily News

Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA

Caitlin E. Cox

August 18, 2023

News Daily News

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

Caitlin E. Cox

August 17, 2023

News Daily News

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

Michael O'Riordan

August 10, 2023

News Daily News

FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction

Caitlin E. Cox

July 27, 2023

News Daily News

Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

Shelley Wood

July 26, 2023

News Daily News

Class I Recall for 350,000 Medtronic Defibrillators: FDA

Michael O'Riordan

July 19, 2023

News Daily News

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

Caitlin E. Cox

June 05, 2023

News Daily News

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Shelley Wood

March 31, 2023

News Daily News

Generic Dabigatran Lots Pulled for Nitrosamine Impurity

Michael O'Riordan

March 28, 2023

News Daily News

New IABP Recall: Balloon Catheter Damage Might Cause Bleeding Into Pump

Shelley Wood

January 25, 2023

News Daily News

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Michael O'Riordan

January 17, 2023

News Daily News

FDA: New Fix Available for Medtronic’s Troubled HeartWare VADs

Michael O'Riordan

October 17, 2022

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Medline Recalls Valve Pack Kits With Expired Cannulas

FDA Issues Safety Communication for Some Accolade Pacemakers

Device Correction Issued for HeartMate Monitor Due to Potential Pump Stoppage

FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

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

Evoque and Patisiran: A Tale of Two Regulatory Journeys

Abiomed Recalls Labeling for Left-Sided Impella Pumps: FDA

FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal

Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA

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

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

FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction

Class I Recall for Amplatzer LAAO's Steerable Delivery Sheath

Class I Recall for 350,000 Medtronic Defibrillators: FDA

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

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Generic Dabigatran Lots Pulled for Nitrosamine Impurity

New IABP Recall: Balloon Catheter Damage Might Cause Bleeding Into Pump

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

FDA: New Fix Available for Medtronic’s Troubled HeartWare VADs

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