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Health Canada recalls St. Jude defibrillators over faulty battery after 2 deaths

Medical device maker St. Jude Medical is warning doctors and patients about a rare battery defect in some of its implantable heart devices that can cause them to fail much earlier than expected.
Medical device maker St. Jude Medical is warning doctors and patients about a rare battery defect in some of its implantable heart devices that can cause them to fail much earlier than expected. Glen Stubbe/Star Tribune via AP, File

Health Canada is recalling several pacemakers built by St. Jude Medical after the company warned doctors and patients about a battery defect.

The batteries of the devices could die earlier than expected, Health Canada warned, with no warning.

READ MORE: Auditor general finds Health Canada not testing cosmetics regularly, no power to recall

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The effected devices are:

  • Fortify Assura DR
  • Fortify Assura VR
  • Fortify DR
  • Fortify ST DR
  • Fortify ST VR
  • Fortify VR
  • Quadra Assura
  • Quadra Assura MP
  • Unify Assura
  • Unify
  • Unify Quadra CRT-D

St. Jude said that two deaths have been linked to the problem with 10 more patients losing consciousness after the devices stopped working. The company did say, however, that the issue is rare: “The vast majority of devices sold worldwide have not experienced premature battery depletion.”

Health Canada is urging anyone using these devices to contact the clinic responsible for their follow-up care immediately.

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Almost 350,000 people around the world have defibrillators affected by the issue.

—with files from The Associated Press

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