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.
Enforcement
- Recall Number
- Z-0079-2018
- Event ID
- 78323
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- November 15, 2017
- Initiation Date
- October 4, 2017
- Classification Date
- November 8, 2017
- Termination Date
- October 15, 2019
- Address
- 4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States
Description
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.
The devices have an incorrect firmware configuration.
Serial numbers 174170, 174349, 174598, and 174606.
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
4 devices