Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0319-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 22, 2020

Date Posted: November 11, 2020

Recall Number: Z-0319-2021

Event ID: 86534

Reason for Recall:

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.

Status: Terminated

Product Quantity: 8 devices

Code Information:

Model 3892 v1.04 is installed on Model 3300 LATITUDE Programming Systems with the following serial numbers: 009494 012689 010356 008206 008124 007983 004813 010751

Distribution Pattern:

Distributed in US - AR, FL, IL, and TX

Voluntary or Mandated:

Voluntary: Firm initiated