Abbott Recalls 465000 Pacemakers for Cybersecurity Patch

31 August, 2017, 01:36 | Author: Valerie Burke
  • Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication - Firmware Update to Address Cybersecurity Vulnerabilities

"This firmware update provides an additional layer of security against unauthorized access to these devices that further reduces the potential for a successful Cybersecurity attack", Abbott said in the letter.

The vulnerabilities, which could allow an attacker to modify the devices' pacing commands or cause premature battery depletion, first came to light in a 2016 report by short-seller Muddy Waters based on research done by cybersecurity firm MedSec Holdings.

To view the full article, register now. Neither organization recommends the prophylactic removal of the devices.

Abbott spokesman Jonathon Hamilton said in a statement Wednesday that Abbott is "resolving all old St. Jude medical issues".

Patients with a RF-enabled St. Jude pacemaker or cardiac pacemaker, as well as healthcare professionals who are using these devices presently in hospitals to treat conditions including heart failure and irregular heart rhythms must make sure a firmware update, approved by the federal agency on 23 August, is applied to these devices.

Contact your Abbott representative, or Abbott's customer technical support hotline at 1‐800‐722‐3774 if you have any questions about the firmware update.

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RECOMMENDATIONS: The firmware update requires an in-person patient visit with a health care provider - it can not be done from home via Merlin.net. St. Jude's Accent, Anthem, Accent MRI, Accent ST, Assurity and Allure pacemakers and cardiac resynchronization therapy (CRT) pacemakers are affected. The risks, which include reloading previous firmware due to an incomplete installation, loss of now programmed settings and loss of device functionality all occur at rates well below 1%.

The FDA stressed this update can not be done from home. Abbott described the full update process in a Dear Doctor letter issued August 28, according to a safety update issued by the FDA.

There haven't been any reports of the vulnerability being exploited in the wild, according to the FDA.

There is a low risk of an update malfunction.

The software patches are in response to U.S health regulators raising concerns about the safety risks of the device early this year. However, officials warned that there is always a potential issue with reloading previous version if the update is incomplete, a loss of programmed settings, loss of diagnostic data and a complete loss of device functionality.

For pacing dependent patients, consider performing the cybersecurity firmware update in a facility where temporary pacing and pacemaker generator can be readily provided.

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