# FDA recall Z-1512-2020

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

## Product

Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

## 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-1512-2020
- **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-1512-2020

## Citation

> AI Analytics. FDA recall Z-1512-2020. Retrieved 2026-06-29 from https://api.ai-analytics.org/recall/Z-1512-2020. Source: US FDA. Licensed CC0.

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