Agency classClass IIOur severity:High FDA (Devices)·Z-1872-2026·Announced 2026-04-29

AccuVu Angiographic Catheter recall due to manufacturing defect

Angiodynamics is recalling AccuVu Angiographic Catheters due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub. The defect could interfere with proper device function during medical procedures.

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: FDA classified this as Class II. The source does not report any illnesses or injuries, but the manufacturing defect creates a risk of harm by preventing proper guidewire passage during a medical procedure, which falls under the High category for risk-of-harm medical devices where injury has not yet been reported.

Plain-English summary

Angiodynamics, Inc. is recalling AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers (Catalog No. 13709005) worldwide. The affected devices contain a manufacturing defect that may prevent an appropriately sized guidewire from passing through the inner diameter of the catheter hub.

The defect could prevent the catheter from functioning as intended during angiographic procedures. Approximately 515 units (103 boxes) have been distributed in the United States and 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.

Healthcare providers and patients who have received or used these catheters should contact Angiodynamics for instructions on device replacement or return. Patients who have concerns about a procedure involving this device should consult their healthcare provider.

The recalled product

Product: AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); Box Quantity: 5 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Angiographic Catheter
Hazard: manufacturing-defect
device-malfunction

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 (10)

ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM
Catalog No.: 13709005
Product/UPN No.: H787137090055 (Box)
H787137090050 (Pouch)
UDI-DI: 25051684005712(Box)
15051684005715(Pouch)
Lot No.: A2725033
A2725034
A3525048
A3525049

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 · manufacturing defect