Boston Scientific recalls Flexiva Pulse 242 TracTip Single-Use Laser Fibers due to potential overheating of the fiber connector that could cause burns if touched. Affected units have specific lot numbers and expiration dates.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
Boston Scientific is recalling Flexiva Pulse 242 TracTip Single-Use Laser Fibers because they may overheat and cause burns if touched during use. This recall affects specific lot numbers and expiration dates.
The fibers were manufactured with an incorrect component that reduces power output and causes the aiming beam to dim. Continued use may lead to overheating at the fiber connector, which could burn skin if touched.
Urology professionals who use these laser fibers for medical procedures are most at risk. The recall applies to specific lot numbers and expiration dates listed in the product description.
Check the lot numbers on the packaging: 30389365, 30389368, 30389369, 30429826, 30479399, 30479580, 30479582, or 30554453. The expiration dates range from October 20, 2025 to November 3, 2025.
Look for lot numbers 30389365, 30389368, 30389369, 30429826, 30479399, 30479580, 30479582, or 30554453 on the packaging.
The product expires between October 20, 2025 and November 3, 2025. Ensure your units are within this date range.
The fibers may overheat at the connector if used incorrectly, potentially causing burns if touched during medical procedures.
Check the lot numbers on the packaging: 30389365, 30389368, 30389369, 30429826, 30479399, 30479580, 30479582, or 30554453. The product expires between October 20, 2025 and November 3, 2025.
No, but you should check the lot numbers and expiration dates to ensure you have a safe product. Continued use may cause overheating and burns.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2229-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2229-2023 from Boston Scientific. 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.