Official recall notice
FDA DeviceClass IINotable
FDA Recall: AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 N
- Recall date
- 2026-04-29
- Brand
- Angiodynamics, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Recommended action
What to do
105 units (21 boxes)
Product description
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.