J&J’s Abiomed Recalls Heart Pump Controllers After 3 Patients Die

J&J’s Abiomed recalls heart pump controllers after 3 patients die

The FDA published an early alert, which the agency reserves for potentially high-risk issues.

J&J’s Abiomed Recalls Heart Pump Controllers After 3 Patients Die - Data Intelligence

Listen to the article 3 min This audio is auto-generated. Please let us know if you have feedback. Dive Brief: Johnson & Johnson’s Abiomed has recalled automated controllers for its Impella heart pumps over a fault linked to three deaths, the Food and Drug Administration said last week. Abiomed’s controllers can fail to detect a pump when connected. No visual alarm is triggered by the fault, which can lead to inadequate hemodynamic support that…

J&J's Abiomed Recalls Blood Pump Controllers After 3 Patient Deaths

An issue may impair the detection of an Impella pump when connected to an AIC.