(MedPage Today) -- The FDA is alerting clinicians to a recall of Boston Scientific's Accolade pacemakers, which have an increased risk of permanently entering "safety mode," possibly requiring early device replacement.
The agency also cleared...

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Recalled Pacemakers; FDA Rejects Full Andexxa Approval; Ticagrelor Back in Hot Seat

FDA warns Boston Scientific pacemaker users may need early replacement due to safety mode issues. Read more here.

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Boston Scientific pacemakers may need early replacement

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Federal health officials are warning that recently recalled Boston Scientific pacemaker devices may begin to malfunction as the battery nears the end of its life cycle, indicating that the defect has been already been linked to at least two fatalities. The U.S. Food and Drug Administration (FDA) issued a safety communication on December 16, warning that certain Boston Scientific Pacemakers may begin to malfunction and cause the devices to enter …

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Boston Scientific Accolade Pacemaker Recall Issued Due to Early Failure Risks

WASHINGTON, D.C., Dec. 16, 2024 (Gephardt Daily) — The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about the potential need for early replacement of Boston Scientific Corporation (Boston Scientific) Accolade pacemaker devices. The devices include: the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Valitude cardiac resy…

Gephardt Daily

Accolade pacemaker devices by Boston Scientific may need early replacement, FDA says

Certain Accolade pacemakers can permanently enter safety mode, which limits the devices’ ability to treat patients properly and requires early replacement.

medtechdive.com

Boston Scientific recalls Accolade pacemakers tied to 2 deaths

The U.S. Food and Drug Administration issued the recall notice for more than 200,000 pacemakers because a battery issue could lock the device in safe mode.

Recalled Pacemakers; FDA Rejects Full Andexxa Approval; Ticagrelor Back in Hot Seat

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