UnratedMedical device recall · FDA · Published October 2, 2018
Medtronic CareLink Encore 29901 Programmer Recall: Cybersecurity Risk
Medtronic recalls CareLink Encore 29901 programmers due to potential cybersecurity risks allowing unauthorized software updates. All units are affected.
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.
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Contact the company
📍Recalling firmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St Ne · Mounds View, MN 55112-4391
“Medtronic CareLink Encore 29901 Programmer Recall: Cybersecurity Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69693-medtronic-carelink-encore-29901-programmer-recall-cybersecurity-risk. Based on FDA recall #Z-0407-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0407-2019%22&limit=1).
The FDA announced on Oct. 2, 2018, that Medtronic Inc. voluntarily recalled its CareLink Encore 29901 Programmer due to cybersecurity vulnerabilities. The agency stated the recall addresses risks allowing unauthorized software updates during SDN downloads.
How to tell if you have it
Brand: Medtronic
Product: CareLink Encore 29901 Programmer
Quantity: 4,072 units
The hazard
The FDA said vulnerabilities in the SDN download process may allow malicious actors to update the programmers with non-Medtronic software. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has had 29 other recalls since Dec. 19, 2017. Recent brand recalls include a May 10, 2023 notice for CRTD CROME HF QUAD MRI IS4 DF1 devices regarding low energy output risks and a June 22, 2022 alert for Cobalt and Crome ICDs concerning reduced shock energy. Other recent recalls of similar products include the Jan. 30, 2026 GE Medical Systems Centricity Universal Viewer Software Cybersecurity Recall and the Oct. 24, 2025 Edan iM20 Patient Monitor Recall for cybersecurity risks.
How to tell if you have this one
The device is the Medtronic CareLink Encore 29901 Programmer. All serial numbers are affected, so any unit purchased by Medtronic is included.
Brand
Medtronic
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide
Recall number
Product, codes & lots
Quantity
Z-0406-2019
Medtronic CareLink 2090 Programmer; All Serial Numbers
30172 units
Z-0407-2019
Medtronic CareLink Encore 29901 Programmer; All Serial Numbers
4072 units
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Identify the serial number on the device to confirm it is affected by this recall.
How this recall unfolded
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0407-2019 (October 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0407-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.