Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

AngioDynamics medical devices: approvals, recalls and adverse events

Stock: ANGO. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 0

PMA approvals

0 supplements

Recalled products

295

0 class I

Adverse event reports

5,846

136 deaths reported

How many recalls does AngioDynamics have?

AngioDynamics has 295 recalled medical device products in 63 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Mar 3, 2026. In 2025 it had 1 recalled products.

How many medical devices has AngioDynamics had cleared or approved?

96 510(k) clearances, 0 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on Mar 24, 2026.

How many adverse event reports name AngioDynamics devices?

5,846 reports in total: 136 deaths, 1,761 injuries and 3,819 malfunctions were reported. 453 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	1	0	0	0
2025	2	0	0	0
2024	2	0	0	0
2023

Newest clearances and approvals

NanoKnife Generator (H78720300351US0)
K253198 · 510(k) clearance · Mar 24, 2026
AlphaVac Multipurpose Mechanical Aspiration System F1885
K252509 · 510(k) clearance · Nov 24, 2025
AngioVac Cannula
K253106 · 510(k) clearance · Oct 24, 2025
NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)
K242687 · 510(k) clearance · Dec 6, 2024
AlphaVac MMA F1885 System (H787253020)
K240397 · 510(k) clearance · Apr 1, 2024
VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits
K231945 · 510(k) clearance · Jul 20, 2023
Solero Microwave Tissue Ablation (MTA) System and Accessories
K223581 · 510(k) clearance · Mar 27, 2023
Solero Microwave Tissue Ablation (MTA) System and Accessories
K221883 · 510(k) clearance · Mar 7, 2023
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
K213388 · 510(k) clearance · Apr 4, 2022
Solero Microwave Tissue Ablation (MTA) System and Accessories
K213067 · 510(k) clearance · Dec 3, 2021

Devices with the most adverse event reports

By product code, all years

Port & Catheter, Implanted, Subcutaneous, Intravascular (LJT, class 2)1,100
Powered Laser Surgical Instrument (GEX, class 2)976
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (LJS, class 2)936
System, Ablation, Microwave And Accessories (NEY, class 2)533
Catheter, Intravascular, Diagnostic (DQO, class 2)376
Catheter, Hemodialysis, Implanted (MSD, class 2)343
Electrosurgical, Cutting & Coagulation & Accessories (GEI, class 2)321
Low Energy Direct Current Thermal Ablation System (OAB, class 2)224
Stents, Drains And Dilators For The Biliary Ducts (FGE, class 2)

All device makers and procedures · ANGO stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to ANGO with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Reports	Deaths
2026	20	279	13
2025	1	453	22
2024	34	374	9
2023	2	303	12
2022	2	240	4
2021	6	294	8
2020	6	332	2
2019	17	287	6
2018	42	370	4
2017	9	381	9
2016	28	384	7
2015	4	489	9
2014	4	332	4
2013	3	241	2
2012	43	275	-

Newest recalls

AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005;
Class II · Mar 3, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H78710714
Class II · Mar 3, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H7871071401
Class II · Mar 3, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140
Class II · Mar 3, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H7871
Class II · Mar 3, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
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;
Class II · Mar 3, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
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.: 1370970
Class II · Mar 3, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215
Class II · Mar 3, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025
Class II · Mar 3, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.
Class II · Mar 3, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath