FDA Recall of AccuVu Angiographic Catheter Due to Manufacturing Defect

Source: FDA · United States

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Angiodynamics, Inc. is recalling 105 units of the AccuVu Angiographic Catheter because of a defect that may prevent guidewires from passing through the device, affecting medical procedures.

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.

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Recall of AccuVu Angiographic Catheter

What Happened

Angiodynamics, Inc. is recalling certain lots of the AccuVu 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 AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; specifically, ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM. The catalog number is 13709804, with Product/UPN numbers H787137098045 (Box) and H787137098040 (Pouch). The UDI-DI numbers are 25051684006085 (Box) and 15051684006088 (Pouch). The recall involves Lot No. A2825131, with a total of 105 units (21 boxes). Distribution was nationwide in the United States and to 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.

What You Should Do

Consumers and healthcare providers who have the affected products should contact Angiodynamics, Inc. for instructions, as the recall was initiated via letter. Stop using the affected devices and follow the firm's guidance for returns or replacements.

Why This Matters

This recall involves medical devices that could impact the safety and effectiveness of procedures, potentially leading to complications for patients in the United States and internationally.

Source

FDA recall notice Z-1875-2026

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 105 units of the AccuVu Angiographic Catheter because of a defect that may prevent guidewires from passing through the device, affecting medical procedures.
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.