FDA Medical Device Recalls (openFDA)
Wilson-Cook Medical Inc.: QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree
- Recall number
- Z-0461-2024
- Recalling firm
- Wilson-Cook Medical Inc.
- Product
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; 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
- 218 devices
- Distribution
- US
- Lot, serial or model codes
- 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
- 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