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.
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
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.
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.
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.
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.
Verify the model number and serial numbers on the stent's distribution label to confirm if it is affected.
No, the UDI error does not cause harm to users. The recall is for tracking purposes only.
Check for the model number 42616 and the specific serial numbers listed: 508083031 through 508083042, or lot number 508083.
Contact Atrium Medical for guidance on next steps, as the recall is for tracking purposes only.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0024-2025 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-0024-2025 from Atrium Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
