Recall archive / FDA device enforcement
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree — FDA record Z-0460-2024
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-6X3, Order Number G22655; 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
- 941 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0460-2024
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 00827002226555 (each), 10827002226552 (case), Lot Numbers: W4721265, W4737428, W4740108, W4741851, W4742110, W4742520, W4742521, W4743198, W4744020, W4744440, W4744875, W4749508, W4752283, W4756468, W4720846, W4721267, W4721796, W4722643, W4722984, W4723305, W4723845, W4737430, W4737767, W4738715, W4739351, W4742522, W4742526, W4743195, W4743196, W4744021, W4744023, W4744443, W4744874, W4744876, W4748041, W4748965, W4749745, W4750014, W4750263, W4751108, W4751109, W4751510, W4751905, W4751907, W4753815, W4753817, W4754120, W4754121, W4754253, W4756473, W4758166, W4758167, W4758929, W4758930, W4760296, W4760714, W4761223, W4762154 |
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.