VIGILANT X4 CRT-D — Class II medical device recall Z-0079-2018
Terminated recall by Boston Scientific Corporation, reported 2017-11-15, distributed in MN, OH. The devices have an incorrect firmware configuration.
| Recall number | Z-0079-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2017-10-04 |
| Classified | 2017-11-08 |
| Reported by FDA | 2017-11-15 |
| Terminated | 2019-10-15 |
| Distributed | MN, OH |
| Quantity | 4 devices |
| Reason classes | software |
| Serial numbers | 174170, 174349, 174598, 174606 |
| Model numbers | G247 |
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.
Reason for recall
The devices have an incorrect firmware configuration.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0079-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.