Recall of Soft-Vu Angiographic Catheter Due to Manufacturing Defect
Angiodynamics, Inc. is voluntarily recalling 4925 units of the Soft-Vu Angiographic Catheter because of a manufacturing defect that may prevent guidewires from passing through.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 2026 and geographically references United States. Its severity classification of "medium" 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 — FDA 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 FDA 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 FDA 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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Recall of Soft-Vu Angiographic Catheter
What Happened
The recall is due to a manufacturing defect in the affected devices, which may prevent the appropriately sized guidewire from passing through the inner diameter of the catheter hub.
Which Products Are Affected
The affected products are the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches; UDI-DI: 25051684007891 (Box), 15051684007894 (Pouch); Lot No.: A2825033, A2825034, A2825132, A2825133, A3725048, A3725049. A total of 4925 units (985 boxes) are involved. The distribution includes US Nationwide and international countries such as Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, and Thailand. The official recall number is Z-1862-2026.
What You Should Do
Consumers should follow the initial firm notification, which was sent via letter, and contact the recalling firm, Angiodynamics, Inc., for further instructions regarding the affected devices.
Why This Matters
This recall involves medical devices used in procedures, potentially affecting patient safety due to the defect that could hinder proper function during use in the United States and worldwide.
Source
Attribution: FDA Recall Notice, Recall Number Z-1862-2026.
Original source: FDA Official Notice ↗
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