Boston Scientific Corporation 2022-11-09 Health serious FDA
Health · FDA · Recall #FDA-Z-0151-2023
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. Recall
Issued November 9, 2022 · Boston Scientific Corporation
In November 2022, Boston Scientific Corporation recalled the EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile., a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
What you should do
- 1 Stop using EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boston Scientific Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Boston Scientific Corporation
- Category
- Health
- Recall date
- November 9, 2022
- Units affected
- Not reported
- 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,
- Recall number
- FDA-Z-0151-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Corporation has 35 recalls in our database, including 13 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.