Boston Scientific Corporation: Medical Device Recall in 2017 - (Recall #: Z-0081-2018)

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:

RESONATE X4 CRT-D, Model G447, Sterile.

Product Classification:

Class II

Date Initiated: October 4, 2017
Date Posted: November 15, 2017
Recall Number: Z-0081-2018
Event ID: 78323
Reason for Recall:

The devices have an incorrect firmware configuration.

Status: Terminated
Product Quantity: 11 devices
Code Information:

Serial numbers 174030, 174900, 174995, 175178, 175328, 175329, 175396, 175440, 175503, 175545, and 175606

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