Biliary balloon dilators recalled for design non-conformance causing detachment
Wilson-Cook Medical is recalling QUANTUM TTC biliary balloon dilators due to design non-conformance. The devices may detach during use, potentially requiring endoscopic retrieval that could cause bleeding.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with design non-conformance creating risk of balloon detachment and potential bleeding from retrieval procedures. No illnesses or injuries reported. Classified as High per rubric criteria for risk-of-harm devices without reported injury.
Plain-English summary
Wilson-Cook Medical Inc. is recalling QUANTUM TTC BILIARY BALLOON DILATOR devices (model REF QBD-10X3-E, Order Number G22667) due to design non-conformance. The recall affects 111 devices distributed in the United States. These devices are used to dilate strictures in the biliary tree.
The devices, while manufactured correctly, do not comply with their design requirements. This non-conformance creates a risk of balloon detachment during clinical use. If detachment occurs, retrieval of the device may be required, which could cause bleeding. Alternatively, the detached device may pass naturally without injury.
Healthcare facilities with devices from the affected lot numbers should refer to the FDA recall notice for details and further instructions from the manufacturer.
The recalled product
- Product
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
- Manufacturer
- Wilson-Cook Medical Inc.
- Affected units
- 111
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00827002227675 (each)
- 10827002227672 (case)
- Lot Numbers: W4739833
- W4749234
- W4750262
- W4756463
- W4756465
- W4720843
- W4722160
- W4722641
- W4723307
- W4724321
- W4739835
- W4740109
- W4740421
- W4746519
- W4747434
- W4748249
- W4749510
- W4749744
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Wilson-Cook Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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