84 results

• 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.

• Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump Recall Issued Due to Risk Blood May Enter Catheter

  January 26, 2023

  Russell Maas

  More than 4,000 Cardiosave intra-aortic balloon pumps are being recalled after being linked to severe injuries, malfunctions, and at least one death.

• Medrol, Similar Glucocorticoids Failed to Improve Infants Heart Surgery Outcomes, Study Warns

  November 8, 2022

  Martha Garcia

  A new study finds glucocorticoids like Medrol do little to help improve outcomes of infants undergoing heart surgery.

• Cerebral Embolic Protection Devices Fail to Prevent Strokes After TAVR Surgery: Study

  October 11, 2022

  Martha Garcia

  A new study finds that cerebral embolic protection devices failed to prevent strokes in TAVR patients.

• FDA Approves New Heater-Cooler System Designed to Prevent Bacterial Contamination That Has Plagued Competitors

  May 9, 2022

  Irvin Jackson

  The FDA has approved a new heater-cooler system that uses a fluid which suppresses the growth of bacterial contamination instead of water.

• Infected Heart Implants Often Left In Place, Despite Risks: Study

  April 13, 2022

  Martha Garcia

  Many patients with heart implant infections choose antibiotics over device removal, despite the higher risk of death, according to the findings of a new study.

• Cardiosave Intra-Aortic Balloon Pump Recall Issued Over Leaks

  December 17, 2021

  Martha Garcia

  The FDA warns that recalled Cardiosave Intra-aortic Balloon Pumps could lead to serious injuries and deaths following reports of one death and more than 70 incidents.

• Surgical Heater-Cooler Devices Carry Risk of Deadly NTM Infections, FDA Warns

  October 14, 2021

  Irvin Jackson

  The FDA has issued new warnings and announced new recalls linked to the use of heater-cooler devices used in heart surgery and the risk of potentially deadly infections.

• 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.

• Study Raises Concerns Over 2-Valve TAVR Surgical Procedure Risks

  May 25, 2021

  Russell Maas

  A new study finds two-valve TAVR procedures may increase the risk of complications and death for heart valve replacement patients.