Home / Recalls / Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) / Z-0407-2019

Z-0407-2019 Class II Ongoing

Recalled by Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) — Mounds View, MN

FDA device recall Z-0407-2019 was initiated by Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) on Oct 2, 2018 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 4072 units.

Recall Details

Product Type: Devices
Report Date: Nov 14, 2018
Initiation Date: Oct 2, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4072 units

Product Description

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.

Distribution Pattern

Worldwide

Code Information

All Serial Numbers

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0407-2019
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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