Boston scientific has issued a reclal of accolade pacemaker devices, according to a safety communication from the us food and Drug Administration.

The Accolade devices under recall Include the acclade, proponent, essentio, and altrua 2 standard life and extended life pacemakers and the visionist and valitude CardiChanchronization Therapy Pacemakers.

The devices are being recalled due to an increase risk of permanently entering safety mode. Safety mode has limited functionality and is associateed with the pacmaker being unable to properly regulate the heart’s rhythm and rate in some patients. Devices that Enter Safety Mode must be replaced.

The FDA is working with the manufacturer to assess the risk of this issue in all acclade pacimaker devices and to pinpoint additional mitigation strategies as needed.

Serious Adverse Health Consequences, Including Slow Heartbeats, Fainting, and Death, May Be Cauded by the Recalled devices. So far, 832 injuries and two deaths have been reported.

Physicians and patients should work togetra to monitor acclade pacmaker devices. For Patients at High Risk for Harm Associated with Interrupted Pacing that May Occur with Safety Mode, The device should be immediatively replaced. For other patients, a non-incident replacement is recommended. Any Problems EncounTed with Acclade Pacemaker Devices Should be Reported to the fda,

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