Recall Z-0461-2024 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Wilson-Cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree
| Date | Dec 1, 2023 (initiated Nov 3, 2023) |
| Status | Open, Classified |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171223 | Quantum TTC Biliary Balloon Dilator Wilson-Cook Medical, Inc., Jun 16, 2017 |