Boston Scientific recalls Flexiva Pulse 242 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 Single-Use Laser Fibers because they may overheat at the connector, causing burns if touched. This risk happens with continued use of the fibers after the laser energy is transmitted.
The fibers may overheat at the connector due to incorrect components, which can cause the aiming beam to dim and reduce efficiency. If the connector gets hot, touching it could result in a burn injury.
Users of urological laser procedures who have the Flexiva Pulse 242 Single-Use Laser Fibers with the specific lot number 30554442 and expiration date 16-Nov-2025 are most at risk. Healthcare professionals using these fibers for urological treatments are affected.
Check for the lot number 30554442 and expiration date 16-Nov-2025 on the packaging. The fibers are single-use and intended for urological procedures with specific model numbers.
Look for the expiration date of 16-Nov-2025 on the packaging to identify affected units.
If the fiber connector feels hot, stop using it immediately to prevent burns.
The specific model number is M006L8405910.
Check for the lot number 30554442 and expiration date 16-Nov-2025 on the packaging.
The recall does not provide a fix; affected users should stop using the product if it overheats.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2228-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2228-2023 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.
