Boston Scientific recalls CRE Wireguided 12-15mm 240cm devices with potential sterile pouch breaches. Affected units have specific lot numbers and expiration dates. Consumers should contact the company for details.
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific is recalling CRE Wireguided 12-15mm 240cm devices due to a risk of sterile pouch breaches during packaging. This could lead to contamination of the medical devices, potentially causing infections if used improperly.
The sterile pouches that hold the devices could be breached during packaging, leading to contamination. If the device is used without proper sterility, it might cause infections in patients during medical procedures.
Medical professionals who use these devices for procedures are most at risk. Patients using the devices may face infection if the sterile packaging is compromised.
Check for the product name 'CRE Wireguided 12-15mm 240cm' on the packaging. Affected units have specific lot numbers listed in the recall notice and expire by October 24, 2028 or February 24, 2029.
Look for the product name 'CRE Wireguided 12-15mm 240cm' and the listed lot numbers on the packaging.
Boston Scientific recalls these devices due to potential sterile pouch breaches during packaging, which could lead to contamination.
Check for the product name 'CRE Wireguided 12-15mm 240cm' and the specific lot numbers listed in the recall notice.
Contact Boston Scientific directly for further instructions on how to handle the affected devices.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2635-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2635-2026 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.
