Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Brand
Wilson-Cook Medical Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Wilson-Cook Medical Inc. is recalling QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures o due to Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment ar. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Cook Medical issued an URGENT: MEDICAL DEVICE REMOVAL notice on 11/03/2023 by mail. The notice explained the problem with the device, risk to health, and requested the following actions be taken: Customer: Cease use, quarantine, and return all affected devices. If devices were further distributed, those to whom the devices were sent must be notified. Distributor: Quarantine all affected devices, notify your customers to whom you distributed devices. Return all devices to Cook Medical.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026