🇨🇦 Soft-Vu and Accu-Vu 4 FR Angiographic Catheters

Hazard/Reason: 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.

This page links to official sources. Verify model/lot/batch details in the official notice.