Agency classClass IIOur severity:High FDA (Devices)·Z-1874-2026·Announced 2026-04-29

AccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall

Angiodynamics recalls AccuVu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The affected devices were distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with a manufacturing defect that prevents proper function. The defect presents a risk of harm by obstructing guidewire passage during an angiographic procedure; however, no illnesses or injuries have been reported in the source text.

Plain-English summary

Angiodynamics, Inc. is recalling AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers (Catalog No. 13709704) due to a manufacturing defect. The affected devices contain a defect in the inner diameter (ID) of the catheter hub that may prevent an appropriately sized guidewire from passing through.

The recalled lot numbers are A3025039 and A3225033. A total of 500 units (100 boxes) have been affected. The devices were distributed worldwide to the United States and internationally to 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.

If you have this product, contact Angiodynamics, Inc. for instructions on how to proceed. Do not use the affected devices and return them to the manufacturer or your supplier.

The recalled product

Product: AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Angiographic Catheter
Hazard: device-defect
functional-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM
Catalog No.: 13709704
Product/UPN No.: H787137097045 (Box)
H787137097040 (Pouch)
UDI-DI: 25051684006030(Box)
15051684006033(Pouch)
Lot No.: A3025039
A3225033

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 recalled by Angiodynamics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

Same manufacturer · Angiodynamics, Inc.

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Same hazard · device defect