Boston Scientific Corporation recalls VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for pat…

Recall date

October 4, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0079-2018

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

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

Why it was recalled

The devices have an incorrect firmware configuration.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.