Wilson-Cook recalls Quantum TTC Biliary Balloon Dilator (QBD-10X3-E) due to potential balloon detachment during use, which may cause injury during retrieval or leave object in body.
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 specific biliary balloon dilator model because some units may detach during procedures, risking injury from retrieval attempts or leaving the object inside the body. This affects medical professionals using the device for biliary strictures.
The device may detach during use, causing the balloon to become stuck in the biliary tract. If retrieved, it could cause bleeding or injury; if not, it might remain in the body without causing harm.
Medical professionals who use the Quantum TTC Biliary Balloon Dilator for biliary strictures. Patients undergoing procedures with this device are at risk if the balloon detaches.
Check for the model number QBD-10X3-E and order number G22667. The device has a unique identifier (UDI/DI) starting with 00827002227675 or 10827002227672. Lot numbers include W4739833 through W4761743.
Look for the model number QBD-10X3-E and order number G22667 on the device or packaging.
Reach out to Wilson-Cook Medical for specific guidance on whether your device is affected and next steps.
The device may have a risk of balloon detachment during use, which could cause injury during retrieval or leave the object in the body. Not all units are affected.
Check the device identification numbers and contact Wilson-Cook Medical for specific guidance on whether your device is affected.
Look for the model number QBD-10X3-E, order number G22667, and unique identifiers starting with 00827002227675 or 10827002227672. Lot numbers include W4739833 through W4761743.
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-0458-2024 — Wilson-Cook Medical Wilson-Cook Medical Hello, I own a Wilson-Cook Medical that is covered by recall Z-0458-2024 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.
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.
