- The FDA has classified another recall of Medtronic Plc’s (NYSE: MDT) HeartWare HVAD ventricular assist device as a Class I event in light of the potential for serious harm.
- Medtronic is recalling 157 HVAD pump implant kits from the U.S. after receiving complaints that some devices have failed to start or restart promptly. Two deaths have been linked to the fault. Other kits have only restarted after a delay.
- The system consists of an implantable pump and an external controller. The company is recalling the pump implant component of HeartWare in light of 29 complaints about the products.
- Some users detected the faults during pre-implant testing.
- The device’s failure could lead to heart attacks, additional procedures, and hospitalizations, as well as worsening heart failure and deaths.
- Price Action: MDT shares are down 0.25% at $117.56 in market trading hours on the last check Tuesday.
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