Boston Scientific Corporation: Medical Device Recall in 2017 - (Recall #: Z-0078-2018)

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 EL ICD DR, Model D433, Sterile.

Product Classification:

Class II

Date Initiated: October 4, 2017

Date Posted: November 15, 2017

Recall Number: Z-0078-2018

Event ID: 78323

Reason for Recall:

The devices have an incorrect firmware configuration.

Status: Terminated

Product Quantity: 12 devices

Code Information:

Serial numbers 530802, 531123, 531237, 531292, 531301, 531446, 531492, 531520, 531536, 531539, 531545, and 531767.

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