QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
FDA device recall Z-0458-2024 · posted 2023-12-01 · Open, Classified
Recall details
- Recalling firm
- Wilson-Cook Medical Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FGE
- Quantity affected
- 111 devices
- Distribution
- US
- Date initiated
- 2023-11-03
- Date posted
- 2023-12-01
- Location
- Winston Salem, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Quantum TTC Biliary Balloon Dilator (K171223) | Wilson-Cook Medical, Inc. | 2017-06-16 |