Class II — Potential Health Hazard

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

CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to There is a SmartSync software issue that results...

Date: April 6, 2021
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

CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).

Quantity: 16,311 devices

Why Was This Recalled?

There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).

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