FDA Recalls Biliary Balloon Dilators Due to Detachment Risk
Wilson-Cook Medical is recalling 941 biliary balloon dilators that may detach during use. Detachment could require doctors to retrieve the device with an endoscope, which may 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 specification non-compliance creating potential for device detachment during medical procedures. No hospitalizations or injuries have been reported; however, potential for bleeding during endoscopic retrieval warrants precautionary action.
Plain-English summary
The QUANTUM TTC BILIARY BALLOON DILATOR (Model QBD-6X3) is a medical device used by doctors to widen narrowed sections of the bile duct during endoscopic procedures. Wilson-Cook Medical Inc. is recalling approximately 941 of these devices that were distributed in the United States.
Some recalled devices do not meet design requirements and may cause the balloon to detach during use. If detachment occurs, the doctor may need to retrieve the device using an endoscope, which could result in bleeding. In some cases, a detached balloon may pass through the body naturally without causing harm.
If you received this device, speak with your healthcare provider. Healthcare providers should stop using these devices immediately and contact the manufacturer for additional instructions and information about affected lot numbers.
The recalled product
- Product
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
- Manufacturer
- Wilson-Cook Medical Inc.
- Affected units
- 941
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 00827002226555 (each)
- 10827002226552 (case)
- Lot Numbers: W4721265
- W4737428
- W4740108
- W4741851
- W4742110
- W4742520
- W4742521
- W4743198
- W4744020
- W4744440
- W4744875
- W4749508
- W4752283
- W4756468
- W4720846
- W4721267
- W4721796
- W4722643
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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