Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medtronic CareLink Encore 29901 Programmer Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to Vulnerabilities have been identified in the SDN download...

Date: October 2, 2018
Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) directly.

Affected Products

Medtronic CareLink Encore 29901 Programmer

Quantity: 4072 units

Why Was This Recalled?

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.

Where Was This Sold?

Worldwide

About Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 198 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report