Quantum TTC Biliary Balloon Dilator Recalled for Balloon Detachment Risk
Wilson-Cook Medical is recalling QUANTUM TTC BILIARY BALLOON DILATORS due to nonconforming devices that may detach during use. Detachment could require endoscopic retrieval and carries a risk of bleeding.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with no reported illnesses, injuries, or hospitalizations. The defect poses potential for serious harm during a medical procedure, fitting the criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Wilson-Cook Medical Inc. is recalling 218 units of the QUANTUM TTC BILIARY BALLOON DILATOR (Model QBD-6X3-E, Order Number G22765) distributed in the United States. These devices are used to dilate strictures of the biliary tree.
The recalled devices do not comply with their design requirements. The balloon may detach from the catheter during use. If detachment occurs, the balloon can become impacted in the biliary tree, potentially requiring endoscopic retrieval. Retrieval procedures carry a risk of bleeding complications. In some cases, a detached balloon may pass naturally without injury to the patient.
Affected lot numbers are: 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, and W4762624.
The recalled product
- Product
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree
- Manufacturer
- Wilson-Cook Medical Inc.
- Category
- Medical Device — Biliary Devices
- Affected units
- 218
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 00827002227651 (each)
- 10827002227658 (case)
- Lot Numbers: W4721269
- W4721794
- W4722640
- W4722986
- W4723306
- W4723844
- W4723847
- W4724322
- W4739837
- W4740113
- W4742111
- W4742513
- W4742524
- W4743194
- W4743197
- W4744442
- W4744872
- W4744873
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Wilson-Cook Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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