FDA-Device2019-02-27Class II

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

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard

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.

Sold states
US and Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic
Affected count
731 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer

Official notice

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

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