Medtronic CareLink Encore 29901 Programmer — Class II medical device recall Z-0407-2019
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2018-11-14. Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious i
| Recall number | Z-0407-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2018-10-02 |
| Classified | 2018-11-08 |
| Reported by FDA | 2018-11-14 |
| Quantity | 4,072 units |
| Reason classes | software |
Product
Medtronic CareLink Encore 29901 Programmer
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0407-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.