Boston Scientific Corporation: Medical Device Recall in 2021 - (Recall #: Z-0879-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)

Product Classification:

Class I

Date Initiated: November 13, 2020

Date Posted: January 27, 2021

Recall Number: Z-0879-2021

Event ID: 87014

Reason for Recall:

There is potential for fractures which results in the inability to delivery therapy.

Status: Terminated

Product Quantity: 47000 units

Code Information:

All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.

Distribution Pattern:

Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region

Voluntary or Mandated:

Voluntary: Firm initiated