Medtronic Halts Sale of Heart Device HVAD System Over Neurological Adverse Events - Medtronic (NYSE:MDT)

Medtronic plc MDT will stop the distribution and sale of its HVAD System and has notified physicians to cease new implants of the HVAD System and transition to an alternative means of durable mechanical circulatory support.
The decision comes after the company's clinical comparisons showed a higher rate of neurological adverse events, including stroke and mortality, with the HVAD System than with other circulatory support devices.
Though the company will stop the distribution and sale of the HVAD System, Medtronic is committed to serving the needs of the approximately 4,000 HVAD patients currently implanted with the device.
Medtronic earlier informed physicians that the HVAD pump might experience a delay to restart or a failure to restart after it was stopped.
Pump restart failure can potentially worsen a patient's heart condition, lead to a heart attack, require hospitalization and result in death, it said.
The HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure.
Financial Impact: Medtronic estimates that the actions announced today are expected to be neutral to slightly accretive to the fiscal year 2022 adjusted diluted EPS.
The HVAD System and associated accessory revenue were $141 million in the fiscal year 2021.
Price Action: MDT shares are up 0.33% at $124.20 during the premarket session on the last check Thursday.