FDA recall Z-0845-2019

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

Product

Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer

Reason for recall

There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some cases disconnecting from the programmer.

Distribution

US and 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: 2019-02-27
Termination date: 2021-03-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0845-2019