FDA Medical Device Recalls (openFDA)
Wilson-Cook Medical Inc.: QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
- Recall number
- Z-0460-2024
- Recalling firm
- Wilson-Cook Medical Inc.
- Product
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
- Status
- Open, Classified
- Initiated
- 2023-11-03
- Posted
- 2023-12-01
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 941 devices
- Distribution
- US
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K171223"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 1037905
- Firm city
- Winston Salem
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28