Agency classClass IIOur severity:High FDA (Devices)·Z-1873-2026·Announced 2026-04-29

AccuVu Angiographic Catheter Manufacturing Defect Recall Worldwide

Angiodynamics is recalling AccuVu Angiographic Catheters worldwide due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.

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 device recall. The manufacturing defect creates a risk of harm—inability to pass a guidewire through the catheter hub could prevent proper clinical function—and no illnesses or injuries are reported in the source text. Per the rubric, Class II recalls with risk of harm but no reported illness score at 3 (High).

Plain-English summary

Angiodynamics, Inc. is recalling AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers (Catalog No. 13709604) due to a manufacturing defect in the affected devices.

The defect may prevent an appropriately sized guidewire from passing through the inner diameter of the catheter hub, potentially compromising the device's intended function during clinical use.

The recalled product was distributed worldwide, including throughout the US 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. A total of 65 units (13 boxes) were affected, identified by Lot No. A2825044.

Patients, healthcare providers, and facility managers who have this product should stop use and contact Angiodynamics, Inc. for further instructions regarding device return or replacement.

The recalled product

Product: AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch); Box Quantity: 5 pouches;
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Angiographic Catheter
Hazard: device-malfunction
manufacturing-defect

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 (7)

ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM
Catalog No.: 13709604
Product/UPN No.: H787137096045 (Box)
H787137096040 (Pouch)
UDI-DI: 25051684005996(Box)
15051684005999(Pouch)
Lot No.: A2825044

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.

See all →

High
Angiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall
FDA (Devices) · 2026-04-29
High
Soft-Vu Angiographic Catheter Cobra Non-Braided Manufacturing Defect
FDA (Devices) · 2026-04-29
High
AccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
High
Soft-Vu Angiographic Catheter Pigtail Non-Braided Guidewire Passage Defect
FDA (Devices) · 2026-04-29
High
Soft-Vu Angiographic Catheter Berenstein Non-Braided Device Recall
FDA (Devices) · 2026-04-29

Same hazard · device malfunction