Recall of Soft-Vu Angiographic Catheter by Angiodynamics
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 voluntarily recalling 950 units of Soft-Vu Angiographic Catheter due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter due to 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, Pigtail, Non-Braided; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); UDI-DI: 25051684007785 (Box), 15051684007788 (Pouch); Lot No.: A2525060, A2525061, A3625006, A3625007. Each box contains 10 pouches, with a total of 950 units (95 boxes) distributed US nationwide 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 recall number is Z-1859-2026.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, and contact Angiodynamics, Inc. for further instructions regarding the affected devices.
Why This Matters
This recall involves medical devices that could impact the safety and effectiveness of procedures, potentially affecting patient care in the United States and internationally.
Source
Source: FDA recall notice, Recall Number Z-1859-2026 (https://www.fda.gov/medical-devices/medical-device-recalls/)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,396 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.