Boston Scientific recalls MoXy Laser Fiber (Material Number 0010-2400) due to potential metal cap and fiber tip breakage during use. Affected units have specific lot numbers listed in the recall notice.
To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.
Boston Scientific is recalling MoXy Laser Fiber (Material Number 0010-2400) because it may break during use, causing metal cap and fiber tip issues. This could lead to complications in surgical procedures if not addressed.
The fiber may break during use, potentially causing metal cap and fiber tip issues. This could lead to complications in surgical procedures if not addressed properly.
Surgical professionals who use the MoXy Laser Fiber for procedures like incision, excision, or coagulation are likely affected. Patients undergoing surgery with this specific product model are at risk.
Check for the product name 'MoXy Laser Fiber' with Material Number 0010-2400. Affected units have specific lot numbers listed in the recall notice.
Look for the lot number on the product packaging or label to determine if it's affected.
The recall indicates potential metal cap and fiber tip breakage during use, so it's recommended to check the lot number and follow the recall instructions.
Check the product lot number against the list provided in the recall notice to see if it's affected. If it is, contact Boston Scientific for further instructions.
Compare your product's lot number with the list of affected lot numbers provided in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1798-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1798-2020 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.
