Angiodynamics, Inc.
26 Forest St, Marlborough, MA, US
Registered product codes
26 product codes
Recent MDR events
2,094 on file
- PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULARJul 30, 2026Malfunction1319211-2026-00262
- Smart Port CTJul 29, 2026Malfunction1319211-2026-00257
- Smart Port CTJul 29, 2026Injury1319211-2026-00254
- Smart Port CTJul 29, 2026Malfunction1319211-2026-00255
- Smart Port CTJul 29, 2026Malfunction1319211-2026-00256
- Smart Port CTJul 29, 2026Injury1319211-2026-00253
- Smart Port CTJul 29, 2026Malfunction1319211-2026-00258
- Smart Port CTJul 29, 2026Injury1319211-2026-00259
- VortexJul 29, 2026Injury1319211-2026-00260
- MarinerJul 28, 2026Malfunction50052622
Recalls
212 on file
- Open, ClassifiedApr 17, 2026
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.
View FDA record ↗ - Open, ClassifiedApr 17, 2026
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.
View FDA record ↗ - Open, ClassifiedApr 17, 2026
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.
View FDA record ↗ - Open, ClassifiedApr 17, 2026
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.
View FDA record ↗ - Open, ClassifiedApr 17, 2026
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.
View FDA record ↗ - Open, ClassifiedApr 17, 2026
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.
View FDA record ↗ - Open, ClassifiedApr 17, 2026
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.
View FDA record ↗ - Open, ClassifiedApr 17, 2026
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.
View FDA record ↗ - Open, ClassifiedApr 17, 2026
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.
View FDA record ↗ - Open, ClassifiedApr 17, 2026
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.
View FDA record ↗
Compliance history
Matched by FEI 1000523114.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.