Class II — Potential Health Hazard

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

Merlin@home RF Remote Monitoring Transmitter Recalled by St Jude Medical Cardiac Rhythm Management Division Due to Transmitter may initiate a software reset resulting in...

Date: December 18, 2014
Company: St Jude Medical Cardiac Rhythm Management Division
Status: Terminated
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 St Jude Medical Cardiac Rhythm Management Division directly.

Affected Products

Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter

Quantity: 257,456 units

Why Was This Recalled?

Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About St Jude Medical Cardiac Rhythm Management Division

St Jude Medical Cardiac Rhythm Management Division has 4 total recalls tracked by RecallDetector.

Related Recalls

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