Wilson-Cook Medical recalls Quantum TTC Biliary Balloon Dilators (QBD-8X3) 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 Medical is recalling certain Quantum TTC Biliary Balloon Dilators (QBD-8X3) because they may detach during use. This could lead to injury from retrieval attempts or the device passing naturally without harm. Patients using these devices should contact the manufacturer for guidance.
The devices may detach during medical procedures, potentially causing injury if the detached balloon needs to be retrieved. This could lead to bleeding or require the device to be removed. In some cases, the balloon may pass naturally without causing harm.
Patients who have received the recalled Quantum TTC Biliary Balloon Dilators for biliary tree procedures are most at risk. Healthcare providers using these devices for medical treatments may also be affected.
Check for the product name 'Quantum TTC Biliary Balloon Dilator', reference number QBD-8X3, and order number G22656. Affected units have specific lot numbers listed in the recall notice.
Reach out to Wilson-Cook Medical to confirm if your device is affected and get instructions for next steps.
The devices may detach during use, which could cause injury during retrieval or allow the device to pass naturally without harm.
Contact Wilson-Cook Medical to determine if your device is affected and follow their instructions.
Yes, the recall includes specific lot numbers listed in the official notice.
We’ve drafted a message you can send Wilson-Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0462-2024 — Wilson-Cook Medical Wilson-Cook Medical Hello, I own a Wilson-Cook Medical that is covered by recall Z-0462-2024 from Wilson-Cook Medical. 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.
