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Terminated

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

FDA Recall Z-0845-2019 · Posted None

Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Recall StatusTerminated
Product CodeOSR
Date Initiated2019-01-17
Date Terminated2021-03-30
Product Quantity731 units

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.

Firm 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 Professional at the account.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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