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Boston Scientific Corporation recalls VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for
Recalled November 15, 2017 · FDA recall Z-0079-2018 · Boston Scientific
Hazard
The devices have an incorrect firmware configuration. · FDA Class II
Units
4 devices
Sold at
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Description
The devices have an incorrect firmware configuration.
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.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →