Wilson-Cook recalls Quantum TTC Biliary Balloon Dilator (QBD-8X3-E) due to potential balloon detachment during use, which could cause injury or require endoscopic retrieval. 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 that may detach during use, potentially causing injury or requiring endoscopic retrieval. This device is used to treat bile duct strictures. Affected units have specific lot numbers and order numbers.
The device may detach during use, which could lead to the need for endoscopic retrieval. This process risks bleeding or injury to the patient. In some cases, the detached object may pass naturally without harm.
Healthcare professionals who use this device for biliary procedures are most at risk. Patients receiving the device during procedures may also be affected if the device is used on the wrong unit.
Check for the model number QBD-8X3-E and order number G22766. Affected units have specific lot numbers listed in the recall notice, including W4756462 through W4762626.
Look for the lot number on the device packaging or label, which should match the listed numbers (W4756462 through W4762626).
Reach out to Wilson-Cook Medical Inc. for further assistance or to confirm if your device is affected.
The model number is QBD-8X3-E with order number G22766.
The device may detach during use, potentially requiring endoscopic retrieval, which could cause bleeding or injury. In some cases, the object may pass naturally without harm.
Check the lot number on the device packaging or label against the list of affected numbers (W4756462 through W4762626).
We’ve drafted a message you can send Wilson-Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0463-2024 — Wilson-Cook Wilson-Cook Hello, I own a Wilson-Cook that is covered by recall Z-0463-2024 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.
