Boston Scientific Wallstent endoprosthesis stents with expired labeling due to sterilization process may not be safe long-term. Recalled for potential shelf life risks.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Boston Scientific's Wallstent stents (12mm x 90mm) are recalled because their expiration date labeling exceeds the actual shelf life due to sterilization process limitations. This could lead to safety issues if used beyond the validated shelf life.
The stents' expiration date on labels is longer than the actual shelf life supported by the sterilization process. This means the stents might degrade or become unsafe after the validated shelf life ends.
Patients who received the recalled Wallstent stents during procedures between specific dates. Medical professionals using these stents for treatments are most at risk.
Check for the model 12MM x 90MM, code number 40213-R, lot number 18030192, and serial numbers 21408032017-10 or 21408032017-11. These stents were sold with specific labeling that expires beyond the validated shelf life.
Review the code number, lot number, and serial numbers to confirm if your stent is in the recalled batch.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for extended shelf life.
Check for the model 12MM x 90MM, code number 40213-R, lot number 18030192, and serial numbers 21408032017-10 or 21408032017-11.
The recall record does not specify a remedy or action for affected stents.
We’ve drafted a message you can send SPS Sterilization to request your refund or repair — edit it as you like.
Subject: Recall Z-3035-2018 — SPS Sterilization SPS Sterilization Hello, I own a SPS Sterilization that is covered by recall Z-3035-2018 from SPS Sterilization. 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.
