Z-0079-2018Class II

VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are...

Name: Z-0079-2018 VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are...
Creator: Boston Scientific Corporation
Published: 2017-10-04
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-10-04 / Terminated / root cause: software

FDA source

Boston Scientific Corporation began a recall of VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive... on 2017-10-04. FDA classified it as Class II and gives the reason as "The devices have an incorrect firmware configuration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0079-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-04
Posted: 2017-11-08
Terminated: 2019-10-15
Recalling firm: Boston Scientific Corporation
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.
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: The devices have an incorrect firmware configuration.
Root cause tag: software
FDA 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 in commerce: 4 devices
Distribution: The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Product codes and lots: Serial numbers 174170, 174349, 174598, and 174606.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0079-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0077-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-08
Z-0078-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-08
Z-0079-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-08
Z-0080-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-08
Z-0081-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-08

Product code NIK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)