FDA recall Z-1522-2021

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Class II · device

Product

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).

Distribution

Worldwide

Key facts

Status: Ongoing
Initiation date: 2021-04-06
Report date: 2021-05-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1522-2021