10 results

• FDA Urges Doctors to “Transition Away” from Certain Getinge Heart Pumps Due to Ongoing Safety Issues

  May 15, 2024

  Martha Garcia

  The FDA is recommending health care professionals "transition away" from using certain Getinge heart devices due to ongoing reports of patient injuries and deaths.

• Facing Few Alternatives, FDA Has Provided Recommendations for Using Recalled Cardiosave Intra-Aorta Balloon Pumps

  September 1, 2023

  Martha Garcia

  The FDA is giving healthcare providers recommendations on how to continue safe use of recalled Cardiosave Intra-Aorta Balloon Pumps due to a lack of alternative devices on the market.

• Recalled Cardiosave Intra-Aorta Balloon Pumps May Unexpectedly Shutdown, Posing Serious Injury Risk for Heart Patients

  August 21, 2023

  Martha Garcia

  About 4,500 Cardiosave intra-aorta balloon pumps have been recalled due to the risk of battery failure and unexpected shutdowns.

• 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.

• Arrow Intra-Aortic Balloon Pump Recall Issued Over Battery Failure Risk

  December 21, 2022

  Martha Garcia

  More than 2,000 intra-aortic balloon pumps have been recalled due to battery failure risks which could endanger heart patients.

• 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.

• LVAD Systems May Cause Worse Outcomes In Heart Attack Patients With Heart Stents: Study

  February 11, 2020

  Martha Garcia

  A new study finds that implanting heart stent patients with an LVAD system increases the risk of death and complications compared with intra-aortic balloon pumps.

• Intra-Aortic Balloon Ruptures Results in Recall Following Three Deaths

  July 2, 2019

  Martha Garcia

  An intra-aorta balloon recall comes following several patient deaths after the heart devices burst or ruptured.

• Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps Recall: Patient Injury Risk

  September 24, 2018

  Russell Maas

  A Marquet/Getinge intra-aortic balloon pump recall comes following revelations that the devices may not work properly at higher altitudes.

• Intra-Aortic Balloon Pumps Should Undergo Clinical Testing: Public Citizen

  February 20, 2013

  Irvin Jackson

  The prominent consumer watchdog group Public Citizen is calling on federal regulators to require that all intra-aortic balloon pumps (IABP)...