Wilson-Cook recalls Quantum TTC Biliary Balloon Dilator (QBD-4X3) due to potential balloon detachment during use, which may 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 certain Quantum TTC Biliary Balloon Dilators (QBD-4X3) because they may detach during medical procedures, risking injury or requiring removal. This recall affects specific lot numbers and order numbers used in biliary tree dilation treatments.
The device may detach during use, potentially causing injury from retrieval attempts or leaving the object to pass naturally without harm. This detachment risk occurs even when the device is manufactured correctly.
Patients undergoing biliary tree dilation procedures with the recalled dilator model are most at risk. Healthcare providers using the device for medical treatments may also be affected.
Check for the model number QBD-4X3 and order number G22654 on the device. Affected units have specific lot numbers listed in the recall notice, including W4720848 through W4762150.
Look for the model number QBD-4X3 and order number G22654 on the device label.
Reach out to Wilson-Cook Medical Inc. for specific guidance on the recall and next steps.
The recalled device is the Quantum TTC Biliary Balloon Dilator with model number QBD-4X3 and order number G22654.
Affected devices have lot numbers from W4720848 to W4762150 as listed in the recall notice.
The recall states potential harms include bleeding from retrieval attempts or injury during removal, but the device may also pass naturally without harm.
We’ve drafted a message you can send Wilson-Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0459-2024 — Wilson-Cook Wilson-Cook Hello, I own a Wilson-Cook that is covered by recall Z-0459-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
