Medtronic, Inc.: Pulse Generator, Permanent, Implantable

Recall Summary Medtronic is recalling certain CareLink SmartSync pulse generators (Model 24967) used in implantable cardiac devices worldwide due to a software problem that may display an inaccurate battery life estimate. The affected devices are permanent implantable pulse generators with RF Head Patient Connectors. This is classified as a Class III recall.

Recalling firm

Medtronic, Inc.

Product

CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable

Reason

Software problem has the potential for an inaccurate displayed longevity estimate.

Classification

Class III

Category

medical device recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-09-24

Status

Open, Classified

Distribution

Worldwide distribution.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/0f9fbbeb-1ce0-4365-9bc1-058067aebb69