The Recall Desk
HighFDA (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.

What this means for you

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.

Related recalls

Same category