Boston Scientific recalls Flexima Regular Kit Nephrostomy Catheter System Kit with potential holes in sterile pouches that could compromise device sterility. Affected units have specific material numbers and expiration dates.
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Boston Scientific is recalling Flexima Regular Kit Nephrostomy Catheter System Kits due to a potential risk of holes in the sterile barrier pouch. This could compromise the sterility of the catheter system during medical procedures.
The device pouch may develop holes that could allow contamination, potentially compromising the sterility of the catheter system during medical procedures. This risk exists if the pouch is not properly sealed during manufacturing or handling.
Patients receiving nephrostomy catheter procedures and healthcare providers using the kit are likely affected. The risk is primarily for medical procedures where sterility is critical.
Check for material number REF M001271860 on the kit packaging. The kit was sold with expiration date 03/04/2027 and lot number 33550953.
Look for material number REF M001271860 on the kit packaging to confirm if it's affected.
The recall addresses a potential risk of holes in the sterile pouch that could compromise device sterility, but it does not indicate immediate injury risk to users.
Check for material number REF M001271860 on the kit packaging. The kit was sold with expiration date 03/04/2027 and lot number 33550953.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance on next steps.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3149-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3149-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
