Wilson-Cook recalls Quantum TTC Biliary Balloon Dilator (QBD-6X3-E) due to potential balloon detachment during use, which could cause injury or require removal. Affected units have specific lot numbers and order numbers.
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Wilson-Cook is recalling a biliary balloon dilator used in medical procedures because some units may detach during use. This could lead to injury or require removal of the device, but the risk is not immediate for all users.
The device may detach during medical procedures, potentially causing injury from retrieval attempts or leaving the object to pass naturally without harm. This noncompliance with design requirements could lead to complications.
Medical professionals who use the Quantum TTC Biliary Balloon Dilator for biliary tree procedures are most at risk. Patients undergoing these procedures with the recalled device may also be affected.
Check for the model number QBD-6X3-E, order number G22765, and lot numbers listed in the recall notice. The device is used for dilating biliary strictures in medical procedures.
Identify the model number QBD-6X3-E, order number G22765, and lot numbers from the list provided in the recall notice.
The recall states that nonconforming devices may detach during use, but the device is designed to work safely when manufactured correctly. The risk depends on specific usage conditions.
The recall does not specify a remedy, so contact Wilson-Cook Medical Inc. directly for guidance on next steps.
Check for the model number QBD-6X3-E, order number G22765, and lot numbers listed in the recall notice.
We’ve drafted a message you can send Wilson-Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0461-2024 — Wilson-Cook Wilson-Cook Hello, I own a Wilson-Cook that is covered by recall Z-0461-2024 from Wilson-Cook. 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.
