Boston Scientific recalls CRE Pro Wireguided 8-10mm 240cm devices with potential sterile breach in packaging. Affected units have specific lot numbers and expiration dates. Consumers should check their product details to determine if they are affected.
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific is recalling CRE Pro Wireguided 8-10mm 240cm devices due to a potential sterile breach in the packaging pouches. This could lead to contamination of the devices before use, which is a serious risk for medical procedures.
The packaging pouches for these medical devices could have a sterile breach, meaning the devices might not be properly sterilized before use. This could lead to contamination during medical procedures, potentially causing infections or other complications.
Medical professionals who use these devices for procedures are most at risk. Patients using these devices for treatments may also be affected if the packaging breach occurs.
Check for the product name 'CRE Pro Wireguided 8-10mm 240cm' with lot numbers listed in the recall (e.g., 38031497, 38031499) and expiration dates up to November 2028 or March 2029.
Look for the product name 'CRE Pro Wireguided 8-10mm 240cm' and specific lot numbers listed in the recall (e.g., 38031497, 38031499) to determine if your device is affected.
Boston Scientific recalls these devices due to a potential sterile breach in the packaging pouches, which could lead to contamination before use.
Check for the product name 'CRE Pro Wireguided 8-10mm 240cm' and specific lot numbers listed in the recall (e.g., 38031497, 38031499) with expiration dates up to November 2028 or March 2029.
The recall does not specify a remedy, so contact Boston Scientific directly for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2627-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2627-2026 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.
