FDA Device recall Z-0462-2024
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656 by Wilson Cook Medical, citing nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0462-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-03 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Wilson Cook Medical |
| Distribution | n/a |
Product
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
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.
Identifiers
| code_info | UDI/DI 00827002226562 (each), 10827002226569 (case), Lot Numbers: W4737768, W4746516, W4746916, W4747433, W4747834, W4…UDI/DI 00827002226562 (each), 10827002226569 (case), Lot Numbers: W4737768, W4746516, W4746916, W4747433, W4747834, W4748247, W4748468, W4748476, W4748944, W4749747, W4750013, W4751335, W4754263, W4756372, W4757274, W4720844, W4721266, W4721791, W4722154, W4722156, W4722983, W4722985, W4724319, W4724691, W4737429, W4737766, W4738716, W4740112, W4746518, W4746918, W4747435, W4747436, W4748248, W4748467, W4748963, W4749746, W4750869, W4751107, W4751110, W4751516, W4752277, W4752278, W4752280, W4752905, W4754118, W4754254, W4754257, W4756474, W4757277, W4758165, W4760467, W4760864, W4761747, W4762155 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0462-2024%22
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