3 results

• Impella Pump Heart Perforation Problems Were Not Adequately Disclosed to FDA: Report

  April 9, 2024

  Russell Maas

  FDA letter accuses Abiomed of not reporting heart-tearing incidents linked to the recalled Impella devices as required by law.

• Impella Left Sided Blood Pump Recall Issued Over Risk of Perforations Due to Faulty Instructions

  March 25, 2024

  Hannah Brown

  The Impella Left Sided Blood Pump recall warns that the device has been linked to heart perforations, resulting in severe injuries and deaths.

• FDA Warns of Medtronic Micra Leadless Pacemaker Heart Perforation Risks

  November 18, 2021

  Russell Maas

  The FDA is warning that Medtronic leadless pacemakers could increase the risk of cardiac perforations, resulting in life-threatening complications.