Recall Z-0845-2019— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2019-01-17, terminated 2021-03-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer. Reason: 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..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-01-17
- Terminated
- 2021-03-30
- Firm location
- Mounds View, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.