HIGHFDA DEVICE

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...

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

AngiodynamicsHealth & Personal CareMedical DevicesACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CMCatalog No.: 13709704Product/UPN No.: H787137097045 (Box)

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
March 3, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
March 3, 2026
Hazard Level
HIGH
Brand
Angiodynamics
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Angiodynamics
Model numbers
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
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 3, 2026

  2. Reported by FDA DEVICE

    April 29, 2026

  3. RecallRadar source check

    May 6, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Angiodynamics, Inc. or your healthcare provider for instructions. Notification method: Letter

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Full Description

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;. Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.. Classification: Class II. Quantity: 500 units (100 boxes). Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
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)
+3 more
Affected States
ALL
Report Date
April 29, 2026
Recall Status
ACTIVE

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