Biliary balloon dilators recalled due to design nonconformity and detachment risk
Wilson-Cook Medical recalled 731 QUANTUM TTC biliary balloon dilators due to design nonconformity that could cause balloon detachment. The device failure may require endoscopic retrieval and risks bleeding complications.
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 medical device recall with potential for serious harm including bleeding and need for endoscopic intervention; however, no illnesses or injuries have been reported, keeping the score at High rather than Severe.
Plain-English summary
Wilson-Cook Medical Inc. has recalled 731 QUANTUM TTC Biliary Balloon Dilator devices (Model QBD-10X3, Order Number G22657) distributed in the United States. The balloons are used to dilate strictures (narrowing) of the biliary tree during endoscopic procedures.
The recalled devices do not comply with their design requirements despite being manufactured correctly. The primary concern is that the balloon may detach from the catheter during use. If this occurs, the detached balloon could remain in the patient's bile duct.
If a balloon detaches, medical intervention may be necessary. Physicians may need to perform endoscopic retrieval to remove the object. This retrieval procedure carries the risk of bleeding complications. In some cases, the object may pass naturally without injury.
Consumers and healthcare providers should stop using these devices immediately. Contact Wilson-Cook Medical Inc. for instructions on device replacement and handling. Specific lot numbers are listed in the FDA recall notice.
The recalled product
- Product
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
- Manufacturer
- Wilson-Cook Medical Inc.
- Category
- Medical Device — Biliary Dilator
- Affected units
- 731
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 00827002226579 (each)
- 10827002226576 (case)
- Lot Numbers: W4746514
- W4746515
- W4753822
- W4756371
- W4756904
- W4720845
- W4721268
- W4722642
- W4722645
- W4722982
- W4723311
- W4724690
- W4738719
- W4739842
- W4740111
- W4746917
- W4747437
- W4747835
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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