Recall Z-1873-2026— Angiodynamics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Angiodynamics, Inc., initiated 2026-03-03. It names 2 FDA 510(k) clearances: K161596, K112452. 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;. 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..
- Recalling firm
- Angiodynamics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-03
- Firm location
- Queensbury, NY, United States
510(k) clearances named in this recall
2 on FDA's record- K161596 — Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
- K112452 — ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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;
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.