FDA Recall of Angiodynamics 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.
The FDA has announced a voluntary recall of 450 units of the Soft-Vu Angiographic Catheter because of a defect that may prevent guidewires from passing through, affecting medical device functionality in the United States 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 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.
FDA Recall of Angiodynamics Soft-Vu Angiographic Catheter
What Happened
The recall was initiated 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. This is a Class II recall, classified as voluntary and firm-initiated.
Which Products Are Affected
The affected product is the Soft-Vu Angiographic Catheter, specifically the Pigtail, Non-Braided model named SOFT-VU PT 4F X 100CM 035 NB 10SH. It has Catalog No.: 10707103, Product/UPN No.: H787107071035 (Box) and H787107071030 (Pouch), UDI-DI: 25051684006177 (Box) and 15051684006170 (Pouch), and Lot No.: A3325043. A total of 450 units (45 boxes) are affected, with each box containing 10 units. 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 initiation date was March 3, 2026, with the official recall number Z-1856-2026.
What You Should Do
Consumers and healthcare providers who have the affected devices should contact the recalling firm, Angiodynamics, Inc., at their address: 603 Queensbury Ave, Queensbury, NY 12804-7619, as initial notification was made via letter. Follow the firm's instructions for returns, refunds, or further guidance to ensure safety.
Why This Matters
This recall affects medical devices used in procedures, potentially impacting patient care by hindering device functionality, and highlights the importance of quality control in healthcare products to prevent any adverse health consequences.
Source
Information sourced from the FDA. For more details, visit the FDA's medical device recalls page at https://www.fda.gov/medical-devices/medical-device-recalls/ and reference event ID 98463.
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 (1,938 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.