Medtronic CareLink Encore 29901 Programmer

Recall Insight

This FDA Devices action (record #Z-0407-2019) was formally reported on November 14, 2018, with the manufacturer initiating the action on October 2, 2018. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is listed as the recalling firm, operating out of Mounds View, MN. Federal records indicate 4072 units units are affected.

The documented reason for this recall is: Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download. Distribution data in the federal record shows the product reached: Worldwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.