Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-0151-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.

Product Classification:

Class II

Date Initiated: September 30, 2022

Date Posted: November 9, 2022

Recall Number: Z-0151-2023

Event ID: 90985

Reason for Recall:

There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

Status: Ongoing

Product Quantity: 7 devices

Code Information:

UPN: 00802526548406; Serial numbers 169276, 169509, 169645, 169774, 169876, 169671, 169297.

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA. The countries of Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated