Recall archive / FDA device enforcement
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree — FDA record Z-0457-2024
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-10X3, Order Number G22657; 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
- 731 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0457-2024
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 00827002226579 (each), 10827002226576 (case), Lot Numbers: W4746514, W4746515, W4753822, W4756371, W4756904, W4720845, W4721268, W4722642, W4722645, W4722982, W4723311, W4724690, W4738719, W4739842, W4740111, W4746917, W4747437, W4747835, W4748251, W4748466, W4748945, W4748964, W4749235, W4749509, W4750012, W4750870, W4750909, W4751106, W4751509, W4752279, W4752282, W4752904, W4752906, W4752907, W4753363, W4753364, W4753366, W4754261, W4754262, W4754850, W4754851, W4755407, W4756476, W4758648, W4758928, W4759512, W4759979, W4760465, W4760865, W4761224, W4762151 |
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.