Angiographic Catheters Recalled Due to Molded Hub Non-Conformance

Health Canada Recalls & Safety Alerts

Filed March 3rd, 2026

Detected March 19th, 2026

Summary

Health Canada has issued a recall for AngioDynamics' Soft-Vu and Accu-Vu 4 FR Angiographic Catheters due to a molded hub non-conformance. The defect may prevent guidewire passage, though no injuries have been reported in Canada. Healthcare providers should contact the manufacturer for information.

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What changed

Health Canada, through its Recalls & Safety Alerts feed, has announced a voluntary medical device field safety corrective action or recall for specific models and lots of Soft-Vu and Accu-Vu 4 FR Angiographic Catheters manufactured by AngioDynamics, Inc. The recall is due to a molded hub non-conformance, which may prevent the appropriately sized guidewire from passing through the catheter hub. While multiple complaints have been received by the manufacturer, no injuries or events have been reported in Canada related to this issue.

Healthcare providers in possession of the affected products are advised to contact the manufacturer, AngioDynamics, Inc., for additional information. This action is classified as a Type II recall, indicating a situation in which use of or exposure to a violative product may cause adverse health events that are temporary and/or medically reversible, or where the probability of adverse health events is remote. While no specific compliance deadline is mentioned, healthcare entities should review their inventory and contact the manufacturer to manage affected devices.

What to do next

Review inventory for affected Soft-Vu and Accu-Vu 4 FR Angiographic Catheters.
Contact AngioDynamics, Inc. for additional information regarding the recall.

Source document (simplified)

Health product recall

Soft-Vu and Accu-Vu 4 FR Angiographic Catheters

Brand(s)

AngioDynamics, Inc.

Last updated

2026-03-18

Summary

Product Soft-Vu and Accu-Vu 4 FR Angiographic Catheters Issue Medical devices - Device compatibility Medical devices - Performance What to do Contact the manufacturer if you require additional information.

Audience Healthcare Industry

Affected products

| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| Soft-Vu Angiographic Catheters: Berentstein: (Braided & Non) | More than 10 numbers, contact manufacturer. | 10714009 |
| Soft-Vu Angiographic Catheters: Berentstein: (Braided & Non) | More than 10 numbers, contact manufacturer. | 10714016 |
| Accu-Vu Sizing Catheter - Pigtail Flush | More than 10 numbers, contact manufacturer. | 13709804 |
| Soft-Vu Angigraphic Catheters: Shepherd Hook (Braided & Non) | More than 10 numbers, contact manufacturer. | H787107100315 |
| Soft-Vu Angiographic Catheters - Omni Flush | More than 10 numbers, contact manufacturer. | 10732301 |
| Soft-Vu Angiographic Catheters - Omni Flush | More than 10 numbers, contact manufacturer. | 10714001 |
| Soft-Vu Angiographic Flush Catheters: Pigtail | More than 10 numbers, contact manufacturer. | 10707103 |
| Soft-Vu Angiographic Flush Catheters: Pigtail | More than 10 numbers, contact manufacturer. | 10714002 |
| Soft-Vu Angiographic Selective Catheters: Cobra (Braided & Non) | More than 10 numbers, contact manufacturer. | 10714018 |
| Soft-Vu Angiographic Selective Catheters: Cobra (Braided & Non) | More than 10 numbers, contact manufacturer. | 10714017 |
| Soft-Vu Angiographic Catheters - Kumpe | More than 10 numbers, contact manufacturer. | 10714021 |
| Soft-Vu Angiographic Catheters - Kumpe | More than 10 numbers, contact manufacturer. | 10714014 |
| Soft-Vu Angiographic Catheters - Kumpe | More than 10 numbers, contact manufacturer. | 10734301 |

Issue

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.

Additional information

Details

Original published date:

2026-03-18

Alert / recall type Health product recall Category Health products - Medical devices - Cardiovascular Health products - Medical devices - Radiology Companies
| AngioDynamics, Inc. |
| 603 Queensbury Avenue, Queensbury, New York, United States, 12804 |
Published by Health Canada Audience Healthcare Industry Recall class Type II Recall date

2026-03-03

Identification number RA-81769