Class II — Potential Health Hazard

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

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS Recalled by Abbott Medical Due to Due to a programmer software anomaly, during finalizing...

Date: November 21, 2024
Company: Abbott Medical
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 Abbott Medical directly.

Affected Products

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

Quantity: 7295 programmers

Why Was This Recalled?

Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Medical

Abbott Medical has 42 total recalls tracked by RecallDetector.

Related Recalls

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