Medtronic said on Thursday it was stopping the distribution and sale of its heart device HVAD System due to safety concerns.
The decision comes after the company’s clinical comparisons showed a higher rate of neurological adverse events with the HVAD System than with other circulatory support devices.
Medtronic earlier informed physicians that the HVAD pump may 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 device, which helps the heart pump and increases the amount of blood that flows through the body of patients with advanced heart failure, is currently used by about 4,000 people.
The HVAD System and associated accessory brought in revenue of $141 million in the fiscal year 2021.
Rival medical device maker Abbott said in a statement on Thursday it had the capacity and supply to support the growing demand for heart pumps. The company sells the HeartMate 3 heart pumps. – Reuters
