Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
QUANTUM TTC BILIARY BALLOON DILATOR Recalled by Wilson-Cook Medical Inc. Due to Nonconforming devices while manufactured correctly, do not comply...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Wilson-Cook Medical Inc. directly.
Affected Products
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Quantity: 731 devices
Why Was This Recalled?
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.
Where Was This Sold?
US
About Wilson-Cook Medical Inc.
Wilson-Cook Medical Inc. has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report