Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer

Recall date

January 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0845-2019

FDA classification

Class II

Brand / firm

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

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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