# FDA recall Z-0319-2021

> **Boston Scientific Corporation** · Class II · device recall initiated 2020-09-22.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0319-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-22
- **Report date:** 2020-11-11
- **Termination date:** 2024-09-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0319-2021

## Citation

> AI Analytics. FDA recall Z-0319-2021. Retrieved 2026-09-10 from https://api.ai-analytics.org/recall/Z-0319-2021. Source: US FDA. Licensed CC0.

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