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

Source: Health Canada · Canada

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AngioDynamics, Inc. is recalling specific Soft-Vu and Accu-Vu 4 FR angiographic catheters because a manufacturing defect in the hub may prevent guidewires from passing through.

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on April 4, 2026 and geographically references Canada. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Product & Food Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly Health Canada detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized Health Canada recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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

Original source: Health Canada Official Notice ↗

All Product & Food Recalls →

Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
AngioDynamics, Inc. is recalling specific Soft-Vu and Accu-Vu 4 FR angiographic catheters because a manufacturing defect in the hub may prevent guidewires from passing through.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.