FDA-Device2021-05-12Class II
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
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).
Sold states
Worldwide
Affected count
16,311 devices
Manufactured in
8200 Coral Sea St Ne, N/A, Mounds View, MN, United States
Products
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1522-2021Don't want to check this manually?
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