Olympus recalls EZDilate Wire Guided Balloons 8.5-10.5 for possible bursting during endoscopic procedures, risking leaks and foreign body complications. Affected units include specific model and lot numbers.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Olympus is recalling certain EZDilate Wire Guided Balloons for possible bursting during endoscopic procedures, which could lead to leaks or foreign body complications in patients. This recall affects specific model numbers and lot ranges sold to medical facilities.
The balloons may burst or leak during inflation, deflation, or retrieval, potentially causing foreign body complications in the patient's alimentary tract. This can lead to prolonged procedures and serious complications if not addressed.
Medical facilities using the affected model numbers (BD-410X-1055) for endoscopic procedures on patients over 12 years old. Patients undergoing dilation procedures with these balloons face the highest risk.
Check for model number BD-410X-1055 and lot numbers 361663, 361664, 365174, 374533, 374534, 375148, 378070, 386123, 386124, or 386395. These were sold for endoscopic dilation in adults and adolescents over 12 years.
Identify the model number (BD-410X-1055) and lot numbers from the list provided in the recall notice.
The balloons may burst or leak during inflation, deflation, or retrieval, potentially causing foreign body complications in the patient's alimentary tract.
The recall notice does not specify a remedy for medical facilities, only identifying affected units.
Yes, the balloons may cause leaks or foreign body complications during endoscopic procedures, which could lead to prolonged procedures and serious complications.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0940-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0940-2024 from Olympus. 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.
