FDAFDA · Food and drugs·Recall number Z-0151-2023
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Published November 9, 2022 · Recall initiated: September 30, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- 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.
- Lot
- UPN: 00802526548406; Serial numbers 169276, 169509, 169645, 169774, 169876, 169671, 169297.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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