Boston Scientific recalls CRE Pro Wireguided 12-15mm 240cm catheters due to potential sterile breach in packaging. Affected units have specific lot numbers and expiration dates. Consumers should check their product details and contact the company for guidance.
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific is recalling CRE Pro Wireguided 12-15mm 240cm catheters because the packaging pouches might have been breached, risking contamination. This could lead to infections if the catheters are used without proper sterility.
The packaging pouches for these catheters may have been breached, potentially allowing contamination. If the catheter is not properly sterilized before use, it could cause infections in patients.
Patients using this specific catheter model for medical procedures are most at risk. The recall affects units with the listed lot numbers and expiration dates.
Check the product label for the lot numbers listed (e.g., 38031635 to 38933956) and expiration dates (November 23, 2028 or March 25, 2029).
Look for the lot numbers listed in the recall (e.g., 38031635 to 38933956) and expiration dates (November 23, 2028 or March 25, 2029).
The packaging pouches may have been breached, potentially allowing contamination. If not properly sterilized, this could lead to infections.
Check the product label for lot numbers from 38031635 to 38933956 and expiration dates of November 23, 2028 or March 25, 2029.
The recall does not require immediate discontinuation. Affected units should be checked for lot numbers and expiration dates.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2629-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2629-2026 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.
