FDA recall Z-0795-2019

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

Product

MEDTRONIC CARELINK 2090 programmer

Reason for recall

There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).

Distribution

US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic

Key facts

Status: Terminated
Initiation date: 2019-01-17
Report date: 2019-02-13
Termination date: 2021-02-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0795-2019