EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0151-2023.
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0151-2023.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Boston Scientific Corporation or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0151-2023.
Boston Scientific Corporation
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Boston Scientific Corporation Recall FAQ
Boston Scientific Corporation is the subject of a medical implants safety report: EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.. The notice was published on September 30, 2022 by the U.S. Food and Drug Administration (FDA). Approximately 7 units are potentially affected.