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 PCS 3650 programmer Model 3330 software Recalled by St. Jude Medical, Cardiac Rhythm Management Division Due to There is a potential for programmer software (Merlin...

Date: June 17, 2022
Company: St. Jude Medical, Cardiac Rhythm Management Division
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 St. Jude Medical, Cardiac Rhythm Management Division directly.

Affected Products

Merlin PCS 3650 programmer Model 3330 software

Quantity: 29,996 programs

Why Was This Recalled?

There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain 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 8 total recalls tracked by RecallDetector.

Related Recalls

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