Boston Scientific recalls Flexiva Pulse ID devices with incorrect components that may cause laser beam dimming and overheating, risking burns. 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 ID devices that may dim the laser beam and cause overheating, potentially leading to burns if touched. This affects devices sold with specific lot numbers and expiration dates.
The device may have incorrect components that reduce laser beam power, causing dimming and overheating. If the fiber connector gets hot, touching it could cause a burn.
Users of Flexiva Pulse ID devices for urological procedures are affected. Those who have the specific lot numbers listed in the recall are most at risk.
Check the lot numbers on the device: 30389427, 30389429, 30389431, 30521475, 30521476, 30521477. The device expires between October 20, 2025 and November 10, 2025.
Look for lot numbers on the device: 30389427, 30389429, 30389431, 30521475, 30521476, 30521477.
Contact Boston Scientific for further instructions if you have the affected lot numbers.
Continued use may cause overheating of the fiber connector, which could result in a burn if touched.
Check the lot numbers: 30389427, 30389429, 30389431, 30521475, 30521476, 30521477. The device expires between October 20, 2025 and November 10, 2025.
Contact Boston Scientific for further instructions if you have the affected lot numbers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2231-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2231-2023 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.
