iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0024-2025.
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0024-2025.
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 Atrium Medical 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-0024-2025.
Atrium Medical 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.
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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.
Atrium Medical Corporation Recall FAQ
Atrium Medical Corporation is the subject of a medical implants safety report: iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616. The notice was published on September 9, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 11 units are potentially affected.