Recall archive / FDA device enforcement
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree — FDA record Z-0461-2024
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-E, Order Number G22765; 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
- 218 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0461-2024
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 00827002227651 (each), 10827002227658 (case), Lot Numbers: W4721269, W4721794, W4722640, W4722986, W4723306, W4723844, W4723847, W4724322, W4739837, W4740113, W4742111, W4742513, W4742524, W4743194, W4743197, W4744442, W4744872, W4744873, W4748250, W4751513, W4751773, W4752903, W4753813, W4753820, W4753821, W4754252, W4755365, W4756464, W4756475, W4757731, W4757734, W4758163, W4758168, W4758649, W4758931, W4759974, W4759978, W4760297, W4760463, W4760464, W4760466, W4760720, W4760859, W4761739, W4761741, W4762144, W4762624 |
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.