# FDA recall Z-3260-2018

> **Boston Scientific Corporation** · Class II · device recall initiated 2018-09-10.

## Product

Model 3300 LATITUDE(TM) Programming System     Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

## Reason for recall

There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.

## Distribution

Worldwide distribution - US Nationwide in the State of  FL, UT,  and VA, and countries of  Austria, Czech Republic, Germany, Greece, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, Switzerland

## Key facts

- **Recall number:** Z-3260-2018
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-10
- **Report date:** 2018-10-03
- **Termination date:** 2021-09-22

- **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-3260-2018

## Citation

> AI Analytics. FDA recall Z-3260-2018. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-3260-2018. Source: US FDA. Licensed CC0.

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