Boston Scientific recalls CRE Pro Wireguided 18-20mm 240cm catheters due to potential sterile pouch breaches in packaging. Affected units have specific lot numbers and expiration dates.
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific is recalling certain CRE Pro Wireguided 18-20mm 240cm catheters because the packaging pouches might not be sterile. This could lead to infections if the catheters are used without proper sterilization.
The packaging pouches for these catheters may not be sterile, which could lead to contamination if the catheters are used without proper sterilization. This poses a risk of infection during medical procedures.
Patients using these catheters for medical procedures are most at risk. Healthcare providers who handle the catheters during procedures may also be affected.
Check for the product name 'CRE Pro Wireguided 18-20mm 240cm' with lot numbers listed in the recall (e.g., 38031485 to 38964093) and expiration dates of November 23, 2028 or March 29, 2029.
Look for the product name and lot numbers listed in the recall notice to confirm if your catheter is affected.
Boston Scientific recalls these catheters because the packaging pouches may not be sterile, which could lead to contamination and infection if used without proper sterilization.
Check for the product name 'CRE Pro Wireguided 18-20mm 240cm' with lot numbers from 38031485 to 38964093 and expiration dates of November 23, 2028 or March 29, 2029.
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-2631-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2631-2026 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.
