Boston Scientific Corporation: Medical Device Recall in 2017 - (Recall #: Z-0079-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 4, 2017

Date Posted: November 15, 2017

Recall Number: Z-0079-2018

Event ID: 78323

Reason for Recall:

The devices have an incorrect firmware configuration.

Status: Terminated

Product Quantity: 4 devices

Code Information:

Serial numbers 174170, 174349, 174598, and 174606.

Distribution Pattern:

The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

Voluntary or Mandated:

Voluntary: Firm initiated