Recall Z-0845-2019 ยท OSR Pacemaker/Icd/Crt Non-Implanted Components
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
| Date | Jan 17, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | In the US, beginning 17-Jan-2019, Medtronic Field Representatives (Field Reps) will locate all Encore programmers both in their trunk stock and in consignment locations. Since the Encore Power Supplies are interchangeable among all Encores, all Encore programmer distributed units are being located, and the associated Power Supplies will be checked to identify any affected units. If the Field Rep identifies an affected Power Supply physically at a customer account, the Medtronic Field Rep will hand deliver a courtesy FCA Notification Letter with instructions to the Risk Manager or HealthCare P |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.