Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent with expired labeling due to sterilization process. Recalled units: 10MM X 94MM | 135CM, resterilized. Contact for remedy.
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 is recalling certain Wallstent RP stents because the expiration date on their labels is longer than the actual shelf life they can safely last. This means the stents might not be safe for use after the labeled expiration date.
The stents have an expiration date that exceeds their actual shelf life due to the sterilization process not supporting extended storage. This could mean the stents become unsafe to use after the labeled expiration date.
Patients who received the recalled stents during procedures between 2020 and 2022 are likely affected. Medical professionals using these specific stents for tracheobronchial procedures are at risk.
Check for the product code 71139-R and lot numbers 17752073 or 17422520. The stents are 10MM X 94MM | 135CM and were resterilized.
Look for the product code 71139-R and lot numbers 17752073 or 17422520 on the stent packaging.
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.
Check for the product code 71139-R and lot numbers 17752073 or 17422520 on the stent packaging.
The recall record does not specify a remedy, so contact Boston Scientific for further instructions.
We’ve drafted a message you can send SPS Sterilization to request your refund or repair — edit it as you like.
Subject: Recall Z-3040-2018 — SPS Sterilization SPS Sterilization Hello, I own a SPS Sterilization that is covered by recall Z-3040-2018 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.