Boston Scientific Corporation: Medical Device Recall in 2023 - (Recall #: Z-2442-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator

Product Classification:

Class II

Date Initiated: July 11, 2023

Date Posted: August 30, 2023

Recall Number: Z-2442-2023

Event ID: 92760

Reason for Recall:

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

Status: Ongoing

Product Quantity: 41,411 units

Code Information:

GTIN: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436; All EMBLEM S-ICDs enrolled in LATITUDE

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated