FDAFDA · Food and drugs·Recall number Z-0079-2018
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.
Published November 15, 2017 · Recall initiated: October 4, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The devices have an incorrect firmware configuration.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
- Lot
- Serial numbers 174170, 174349, 174598, and 174606.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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