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Medical Devices / Submissions and Approvals

Abbott Recalls 465,000 Pacemakers for Cybersecurity Patch

Sept. 5, 2017

Abbott announced a voluntary recall of 465,000 pacemakers to install a firmware update to patch cybersecurity vulnerabilities in the devices.

The recall affects six pacemaker models—Accent, Accent MRI, Accent ST, Allure, Anthem and Assurity—that Abbott acquired when it completed its purchase of St. Jude Medical last January.

The devices made as of Aug. 28 will come pre-patched with the update, and both the company and FDA say that already-implanted devices should not be physically replaced due to cybersecurity concerns.

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