Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls CareLink SmartSync Device Manager (24970A). used to interro
Recalled Product
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Hazard / Issue
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
Issued by
FDA
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