Wilson-Cook recalls specific Quantum TTC Biliary Balloon Dilators (QBD-6X3) due to potential balloon detachment during use, which could cause injury or require removal. Affected units have unique identifiers and lot numbers listed in the recall.
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-6X3) because they may detach during use, potentially causing injury or requiring removal. This recall affects medical devices used to treat biliary strictures.
The devices may detach during endoscopic procedures, leading to the need for retrieval of an impacted object, bleeding, or the object passing naturally without injury. This detachment risk occurs even when the device is manufactured correctly.
Patients who have received the recalled Quantum TTC Biliary Balloon Dilators for biliary stricture treatment are most at risk. Healthcare providers using these devices for medical procedures may also be affected.
Check for the product model QBD-6X3 with Order Number G22655. Affected units have unique identifiers (UDI/DI 00827002226555 per unit, 10827002226552 per case) and specific lot numbers listed in the recall.
Identify the product model, order number, and lot numbers to confirm if your device is affected.
Reach out to your doctor or healthcare provider to determine if you have the recalled device and discuss next steps.
The recalled device is the Quantum TTC Biliary Balloon Dilator with model reference QBD-6X3 and Order Number G22655.
Check for the unique identifiers (UDI/DI 00827002226555 per unit, 10827002226552 per case) and specific lot numbers listed in the recall.
Contact your healthcare provider to determine if you have the recalled device and discuss next steps.
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-0460-2024 — Wilson-Cook Medical Wilson-Cook Medical Hello, I own a Wilson-Cook Medical that is covered by recall Z-0460-2024 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.
