Recall Z-0079-2018 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Boston Scientific Corporation
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 bl
| Date | Oct 4, 2017 |
| Status | Terminated |
| Reason | The devices have an incorrect firmware configuration. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters dated October 2017 on 10/4/2017 via delivery by the sales representative. |
| Quantity | 4 devices |
| Distribution | The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.