PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: February 27, 2019 Initiated: January 17, 2019 #Z-0845-2019

Product Description

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.

Details

Units Affected
731 units
Distribution
US and Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic
Location
Mounds View, MN

Frequently Asked Questions

What product was recalled?
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 731 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 27, 2019. Severity: Moderate. Recall number: Z-0845-2019.