Product Wiki · Recalls · Health Canada — Medical Devices

HURRICANE RX BILIARY BALLOON DILATATION CATHETER (2020-09-16) — recall 61650

Health Canada — Medical Devices · Canada · 2020-10-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61650
Date of alert
2020-10-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Boston Scientific Corporation (BSC) initiated a removal of specific lots/batches of Hurricane RX Biliary Balloon Dilatation Catheters in response to an increase in complaints of the RX tunnel component (blacksheath) detaching from the catheter shaft. Investigation has shown this is due to a lower bond strength of the tunnel component which may lead to detachment.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/hurricane-rx-biliary-balloon-d

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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