FDA Issues Recall for Soft-Vu Angiographic Catheter Due to Manufacturing Defect
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 5155 units of the Soft-Vu Angiographic Catheter because of a defect that may prevent guidewires from passing through the catheter hub, affecting devices 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 7, 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 the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided, with Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box) and H787107343010 (Pouch); Box Quantity: 5 pouches. A total of 5155 units (1031 boxes) are involved, with Lot No.: A2825021, A2825129, A3325027, A3425027, A3525014, and A3825095. The distribution includes US Nationwide and 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 recall number is Z-1871-2026.
What You Should Do
Consumers and healthcare providers should follow the initial firm notification via letter and contact Angiodynamics, Inc. at their address: 603 Queensbury Ave, Queensbury, NY 12804-7619, for information on returns or refunds related to the affected lots.
Why This Matters
This recall involves medical devices that could impact patient safety during procedures, potentially leading to complications if the defect occurs, and affects a significant number of units distributed worldwide.
Source
Attribution: FDA Recall Number Z-1871-2026. For more information, visit the FDA website using the recall number.
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 (1,519 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.