7 results

• Abbott Recalls Trifecta Heart Valves From U.S. Market Amid Concerns About Early Deterioration Problems

  August 1, 2023

  Russell Maas

  Abbott is pulling its Trifecta Heart Valves from the market due to the risk of early deterioration and failure, which has been linked to nearly 200 deaths.

• FDA Warns Doctors of Abbott Trifecta Valve Deterioration Risks

  February 28, 2023

  Russell Maas

  The FDA warns that Abbott Trifecta heart valve implants may deteriorate within only a few years, leading to the need for valve replacement and increasing the risk of patient death.

• Abbott MitraClip Warning Issued By FDA Over Clip Lock Malfunctions

  September 9, 2022

  Martha Garcia

  The FDA warns that MitraClip heart valve repair devices may malfunction, resulting in a backflow of blood into the heart.

• Combining Surgical Heart Valve Replacement and Pacemakers May Put Patients’ Hearts at Risk: Study

  July 14, 2021

  Russell Maas

  Implanting pacemakers into recent heart valve replacement patients may increase their risk of death, according to the findings of a new study.

• Adding Plavix To Aspirin Provides No Benefit, But May Increase Bleeding Risk For Heart Valve Patients: Study

  October 9, 2020

  Irvin Jackson

  A new study warns that giving Plavix and aspirin to heart valve replacement patients may increase their risk of bleeding events.

• FDA Issues New Draft Guidance On Testing Medical Devices For Use In MRIs

  August 13, 2019

  Martha Garcia

  The FDA has issued a draft guidance on how to determine what medical devices can enter an MRI machine safely.

• Bioprosthetic Heart Valve Problems May Lead to Blood Clot, Stroke Risk: Study

  October 7, 2015

  Irvin Jackson

  Some bioprosthetic heart valves are not opening and closing normally, raising concerns within the FDA, which is trying to develop new studies to see if the reduced motion is a threat to patients.