Recall archive / FDA device enforcement
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree — FDA record Z-0459-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 3, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Wilson-Cook Medical Inc.
- Quantity
- 553 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0459-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, W4748043, W4748946, W4749748, W4750264, W4750265, W4750910, W4751772, W4751906, W4751914, W4753360, W4753361, W4753362, W4753365, W4753816, W4755138, W4756901, W4756903, W4756905, W4757732, W4758647, W4759511, W4759976, W4760715, W4761738, W4761740, W4761935, W4762150 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 13, 2023
- Recall initiation date
- Nov 3, 2023
- Center classification date
- Dec 1, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.