Recalls / —
—#159186
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.
- FDA product code
- NIK — Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P960040, P010012
- Affected lot / code info
- Serial numbers 174170, 174349, 174598, and 174606.
Why it was recalled
The devices have an incorrect firmware configuration.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
The recalling firm issued letters dated October 2017 on 10/4/2017 via delivery by the sales representative.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700
Distribution
- Distribution pattern
- The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Timeline
- Recall initiated
- 2017-10-04
- Terminated
- 2019-10-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #159186. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.