FDA Recalls Quantum TTC Biliary Balloon Dilators Due to Design Nonconformance
Wilson-Cook Medical recalls 553 Quantum TTC Biliary Balloon Dilators that do not meet design specifications, creating risk of balloon detachment during endoscopic procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a medical device with potential for serious complications (balloon detachment requiring endoscopic retrieval and risk of internal bleeding). No illnesses, injuries, or deaths have been reported, placing this in the High category for risk-of-harm products without reported actual injury.
Plain-English summary
Wilson-Cook Medical Inc. is recalling 553 Quantum TTC Biliary Balloon Dilator devices (Model QBD-4X3) distributed in the United States. These devices are identified by specific lot numbers provided by the FDA.
The recalled devices do not comply with their design specifications. This nonconformance creates a risk of balloon detachment during endoscopic procedures. If detachment occurs, the device may require endoscopic retrieval, which can cause internal bleeding and other complications. In some cases, the detached balloon may pass through the body naturally without causing injury.
Healthcare providers and hospitals using these devices should discontinue use immediately and verify whether they have affected lot numbers. Contact Wilson-Cook Medical or the FDA for instructions on device return or safe disposal. Patients who have had procedures with these devices should contact their healthcare provider if they experience symptoms or complications.
The recalled product
- Product
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
- Manufacturer
- Wilson-Cook Medical Inc.
- Hazard
- balloon-detachment
- internal-bleeding
- device-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00827002226548 (each)
- 10827002226545 (case)
- Lot Numbers: W4720848
- W4721792
- W4721795
- W4722159
- W4722981
- W4723304
- W4723846
- W4724692
- W4737576
- W4738717
- W4742525
- W4743193
- W4743605
- W4743606
- W4743607
- W4743608
- W4744022
- W4744441
Distribution
Distribution scope not specified by the agency.
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