# FDA recall Z-1511-2020

> **Boston Scientific Corporation** · Class II · device recall initiated 2020-02-12.

## Product

Boston Scientific, LATITUDE Programming System, Model 3300 - 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

Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.

## Distribution

US Nationwide distribution in the states of NC, TN, and MO.

## Key facts

- **Recall number:** Z-1511-2020
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-12
- **Report date:** 2020-03-25
- **Termination date:** 2023-04-14

- **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-1511-2020

## Citation

> AI Analytics. FDA recall Z-1511-2020. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1511-2020. Source: US FDA. Licensed CC0.

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