FDA-Device2022-11-09Class II
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Hazard
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Sold states
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.
Affected count
7 devices
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0151-2023More Boston Scientific Corporation recalls
- FDA-Device2026-07-08CRE Pro Wireguided 12-15mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 10-12mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 15-18mm 240cm
- FDA-Device2026-07-08CRE Pro Wireguided 6-8mm 240cm
- FDA-Device2026-07-08CRE Wireguided 8-10mm 240cm
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief