Recall Z-1522-2021— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Name: FDA recall Z-1522-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-06

Class II · Ongoing

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2021-04-06. FDA's recall record names no specific 510(k) clearance for this event. Product: CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).. Reason: 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)..

Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Classification: Class II
Status: Ongoing
Initiated: 2021-04-06
Firm location: Mounds View, MN, United States

Product description

CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.