Boston Scientific Corporation recalls EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.

Recalled November 9, 2022 · FDA recall Z-0151-2023 · Boston Scientific

Hazard

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

Units

7 devices

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →