FDA Recalls Pacemakers Due to Hacking Vulnerability

The Food and Drug Administration has issued a recall for almost half a million pacemakers due to vulnerabilities discovered in the software that would allow a hacker to modify the code, and, possibly, cause life-threatening issues for patients that depend on them.

The affected devices are manufactured by Abbot (previously St. Jude Medical), and the FDA has stated that they can, luckily, be repaired without being surgically removed.

According to the report by the FDA, the following list of St. Jude Medical pacemaker and CRT-P device models are included in this recall:

  • Accent
  • Anthem
  • Accent MRI
  • Accent ST
  • Assurity
  • Allure

However, the FDA clarifies that this recall “does NOT apply to any implantable cardiac defibrillators (ICDs) or to cardiac resynchronization ICDs (CRT-Ds)”.

The firmware update to fix the issue will require an in-person visit to your physician. If you or someone you know has a pacemaker, please make sure they hear about this recall.

For more information, please read the original FDA report.

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