AngioDynamics Recalls Soft-Vu and Accu-Vu 4 FR Angiographic Catheters Due to Hub Defect

What Happened

AngioDynamics, Inc. has initiated a voluntary medical device field safety corrective action for specific models and lots of Soft-Vu and Accu-Vu 4 FR angiographic catheters. The recall was prompted by a manufacturing defect in a molded hub that may prevent an appropriately sized guidewire from passing through the inner diameter of the catheter hub. While the company has received multiple complaints regarding this non-conformance, no complaints or events have been reported in Canada, and there are no reports of patient injury associated with this issue.

Which Products Are Affected

The recall affects specific models and lots of Soft-Vu and Accu-Vu 4 FR angiographic catheters. Because more than 10 lot numbers are involved for each model, consumers are advised to contact the manufacturer for specific lot identification. Affected models include:

• Soft-Vu Angiographic Catheters: Berentstein (Braided & Non): Model numbers 10714009, 10714016
• Accu-Vu Sizing Catheter - Pigtail Flush: Model number 13709804
• Soft-Vu Angiographic Catheters: Shepherd Hook (Braided & Non): Model number H787107100315
• Soft-Vu Angiographic Catheters - Omni Flush: Model numbers 10732301, 10714001
• Soft-Vu Angiographic Flush Catheters: Pigtail: Model numbers 10707103, 10714002
• Soft-Vu Angiographic Selective Catheters: Cobra (Braided & Non)

What You Should Do

Healthcare providers and end-users should immediately check their inventory for the affected model numbers. Because the recall involves a large number of lots, users should contact AngioDynamics, Inc. directly to confirm if their specific units are included in the recall. The company is located at 603 Queensbury Avenue, Queensbury, New York, 12804.

Why This Matters

This recall is necessary to prevent potential procedural delays or complications that could arise if a guidewire is unable to pass through the catheter hub during a medical procedure.

Source

Health Canada