The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1875-2026·Announced 2026-04-29

AccuVu Angiographic Catheter recalled for guidewire passage defect

Angiodynamics is recalling the AccuVu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a properly sized guidewire 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 medical device recall where a manufacturing defect prevents proper device function during a critical clinical procedure. Although no illnesses or injuries are reported in the source text, the risk-of-harm nature of a guidewire passage obstruction during an interventional vascular procedure justifies a High severity rating.

Plain-English summary

Angiodynamics, Inc. is recalling the AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers (Catalog No. 13709804; Product/UPN Nos. H787137098045 and H787137098040; Lot No. A2825131). 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 product was distributed worldwide, including throughout 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. A total of 105 units across 21 boxes were affected.

Patients and healthcare providers who have received or are using this product should stop using it and contact Angiodynamics, Inc. directly for instructions on device return or replacement. Healthcare facilities should check their inventory for the affected lot and remove it from clinical use.

The recalled product

Product
AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch); Box Quantity: 5 pouches;
Manufacturer
Angiodynamics, Inc.
Category
Medical Device — Interventional Cardiology / Vascular
Hazard

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 PT 4F X 70CM 035 NB 10SH 21 R/O 1CM
  • Catalog No.: 13709804
  • Product/UPN No.: H787137098045 (Box)
  • H787137098040 (Pouch)
  • UDI-DI: 25051684006085(Box)
  • 15051684006088(Pouch)
  • Lot No.: A2825131

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 →

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