# FDA recall Z-0079-2018

> **Boston Scientific Corporation** · Class II · device recall initiated 2017-10-04.

## Product

VIGILANT X4 CRT-D, Model G247, Sterile.      Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.

## Reason for recall

The devices have an incorrect firmware configuration.

## Distribution

The devices were distributed to medical facilities located in MN and OH.  There was no foreign/government/military distribution.

## Key facts

- **Recall number:** Z-0079-2018
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-04
- **Report date:** 2017-11-15
- **Termination date:** 2019-10-15

- **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-0079-2018

## Citation

> AI Analytics. FDA recall Z-0079-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0079-2018. Source: US FDA. Licensed CC0.

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