Product Wiki · Recalls · Health Canada — Medical Devices

Soft-Vu and Accu-Vu 4 FR Angiographic Catheters — recall 81769

Health Canada — Medical Devices · Canada · 2026-03-18 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
81769
Date of alert
2026-03-18
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Cardiovascular - Radiology
Product type
Medical devices
Reported risk: AngioDynamics, Inc., is conducting a voluntary medical device field safety corrective action or recall to the end-user level based on the non-conformance of a molded hub in specific models and lots of Soft-Vu and Accu-Vu 4 fr angiographic catheters. The affected Soft-Vu and Accu-Vu 4 fr angiographic catheters being recalled (removed) contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. AngioDynamics has become aware of the non-conformance by way of multiple complaints associated with the affected angiographic catheter devices; however, there have been no complaints or events that occurred in Canada. There are no reports of patient injury as a result of this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/soft-vu-and-accu-vu-4-fr-angio

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