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Recall: Abbott Pacemakers for Hacking Threat

pacemaker surgery graphic illustration

Sept. 5, 2017 -- The FDA announced a voluntary recall for a brand of pacemakers over concerns the devices’ software could be hacked.

The recall affects 465,000 pacemakers sold by Abbott, formerly St. Jude Medical.

The devices, “if exploited, could allow an unauthorized user (i.e. someone other than the patient’s physician) to access a patient’s device using commercially available equipment,” the FDA said.

Abbott has created new software with more security measures. The update includes data encryption, operating system patches, and the ability to disable network connections, according to a statement from the company.

The impacted pacemakers include the RF telemetry versions of the following devices in the U.S.:

  • Accent SR RF
  • Accent MRI
  • Assurity
  • Assurity MRI
  • Accent DR RF
  • Anthem RF
  • Allure RF
  • Allure Quadra RF
  • Quadra Allure MP RF

There have been no known reports of people being harmed. If you have any further questions, contact your doctor, call 800-722-3774 (in the U.S.), or visit www.sjm.com/cyberupdate.

WebMD Article Reviewed by Neha Pathak, MD

Sources

FDA: “Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott's (formerly St. Jude Medical's) Implantable Cardiac Pacemakers: FDA Safety Communication.”

St. Jude Medical: “August 29, 2017 Cybersecurity Pacemaker Firmware Release Update.”

Abbott: “Abbott Issues New Updates For Implanted Cardiac Devices.”

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