FDA recall Z-0241-2020

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

Product

Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager

Reason for recall

There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.

Distribution

Worldwide Distribution

Key facts

Status: Ongoing
Initiation date: 2019-10-03
Report date: 2019-11-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0241-2020