FDA Recall of Soft-Vu Angiographic Catheter by Angiodynamics

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Angiodynamics, Inc. is recalling 1520 units of Soft-Vu Angiographic Catheter due to a manufacturing defect that may prevent guidewires from passing through the device, affecting products distributed nationwide in the US and internationally.

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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Angiodynamics, Inc. is recalling certain Soft-Vu Angiographic Catheters because of a manufacturing defect that may prevent the appropriately sized guidewire from passing through the inner diameter of the catheter hub.

Which Products Are Affected

The affected products are Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH. Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); UDI-DI: 25051684007853 (Box), 15051684007856 (Pouch); Lot No.: A2825134, A2825153, A3825063. A total of 1520 units (304 boxes) are involved, distributed nationwide in the United States and in countries including 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-1860-2026.

What You Should Do

Consumers and healthcare providers with the affected products should contact Angiodynamics, Inc. via the initial firm notification letter for instructions on returns or refunds. The firm's address is 603 Queensbury Ave, Queensbury, NY 12804-7619.

Why This Matters

This recall highlights potential risks in medical devices that could affect procedural outcomes, emphasizing the importance of device reliability in healthcare settings.

Source

FDA Recall Number: Z-1860-2026

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Angiodynamics, Inc. is recalling 1520 units of Soft-Vu Angiographic Catheter due to a manufacturing defect that may prevent guidewires from passing through the device, affecting products distributed nationwide in the US and internationally.
Which agency issued this alert?
This alert was issued by FDA. 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 "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.