Class II — Potential Health Hazard

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

Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA Recalled by Boston Scientific Corporation Due to There is potential when a user changes an...

Date: September 22, 2020
Company: Boston Scientific Corporation
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 Boston Scientific Corporation directly.

Affected Products

Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application

Quantity: 8 devices

Why Was This Recalled?

There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.

Where Was This Sold?

This product was distributed to 4 states: AR, FL, IL, TX

Affected (4 states)Not affected

About Boston Scientific Corporation

Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.

Related Recalls

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