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Official recall record

Quantum TTC® Biliary Balloon Dilator

Health Canada — Medical Devices · 2023-11-20 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2023-11-20
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

Wilson-Cook Medical, Inc. is initiating a voluntary removal of affected QBD devices from the market because they are nonconforming. They are manufactured correctly, but do not comply the design requirements. Devices were not able to inflate without leakage. Recall start date: November 3, 2023

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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