Medtronic Recalls HeartWare HVAD System Batteries For Electrical Faults

  • Medtronic Plc MDT is recalling HeartWare HVAD System batteries because they may experience electrical faults that cause the system to fail unexpectedly. 
  • The HeartWare Ventricular Assist Device (HVAD) System is used to help the heart continue to pump blood to the rest of the body. 
  • The HVAD system is used as a bridge to cardiac transplants in patients at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients for whom heart transplants are not planned. 
  • The system operates using power from either AC or DC electricity or batteries.
  • If the battery fails and the patient is unable to replace the failed battery with a charged, working battery or with AC or DC power, the HVAD may stop working, leading to serious injury or death.
  • Medtronic reports 1,159 complaints, six injuries, and one death related to this issue.
  • Medtronic will recall over 23,000 Medtronic HVAD Batteries distributed after January 2009.
  • Last week, the company announced to recall Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Resynchronization Therapy Defibrillators (CRT-Ds) after receiving reports of devices with short circuit protection (SCP) alert resulting in reduced-energy electric shock delivery, instead of delivering the second phase of high voltage therapy.
  • Medtronic's ICDs and CRT-Ds are implantable cardiac devices that monitor and regulate heart rate and rhythm.
  • Price Action: MDT shares are up 2.37% at $91.40 on the last check Thursday.
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