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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Recalled May 12, 2021 · FDA recall Z-1522-2021 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
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). · FDA Class II
Units
16,311 devices
Sold at
Worldwide
Description
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).
Product
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →