Atrium Medical iCast Stent Recall: UDI Label Error
Atrium Medical recalls iCast Covered Stent Model 42616 due to a UDI label error. Affected units have specific serial numbers and lot numbers. Contact for replacement.
Lower-risk recall
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Contact the company
What happened, in plain English
Atrium Medical is recalling a specific model of covered stent due to an error in the Unique Device Identifier (UDI) printed on the product's label. This error means the stent might not be properly tracked, but it does not pose a safety risk to users. Read more at govinfonow.com/recall/54038-atrium-medical-icast-stent-recall-udi-label-error.
Source Summary by GovInfoNow · govinfonow.com/recall/54038-atrium-medical-icast-stent-recall-udi-label-error · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0024-2025
Cite this page
“Atrium Medical iCast Stent Recall: UDI Label Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54038-atrium-medical-icast-stent-recall-udi-label-error. Based on FDA recall #Z-0024-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0024-2025%22&limit=1).
Why it’s dangerous
The UDI label error means the stent's unique identification code is incorrect. This could lead to tracking issues during medical procedures, but it does not cause harm to patients or users in normal use.
Who’s affected
Patients who own the iCast Covered Stent Model 42616 with the listed serial numbers or lot number are affected. Medical professionals using this stent for procedures are at risk if they have the incorrect UDI.
How to tell if you have this one
Check for the model number 42616 on the stent's label. Look for the specific serial numbers listed: 508083031 through 508083042, and lot number 508083.
- Brand
Atrium Medical- Category
Medical device
What to do — step by step
Check Label Details
Verify the model number and serial numbers on the stent's distribution label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “US Nationwide distribution in the states of FL, MA, MI, OH, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Massachusetts, Michigan, Ohio, Washington.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0024-2025 (September 9, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0024-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.