Angiodynamics, Inc.
FDA adverse event reports naming Angiodynamics, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ANGIODYNAMICS, INC..
- Total reports
- 1,383
- Deaths
- 40
- Injuries
- 413
- Malfunctions
- 883
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Port & Catheter, Implanted, Subcutaneous, IntravascularLJT254
- Powered Laser Surgical InstrumentGEX197
- Catheter, Intravascular, DiagnosticDQO167
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysLJS150
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI108
- System, Ablation, Microwave And AccessoriesNEY102
- Low Energy Direct Current Thermal Ablation SystemOAB88
- Catheter, Angioplasty, Peripheral, TransluminalLIT78
- Catheter, Hemodialysis, ImplantedMSD38
- Dilator, Vessel, For Percutaneous CatheterizationDRE28
Recent recalls
- 2026-04-17Open, ClassifiedNonconforming Material/Component
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;
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.
- 2026-04-17Open, ClassifiedNonconforming Material/Component
Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;
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.
- 2026-04-17Open, ClassifiedNonconforming Material/Component
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;
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.
- 2026-04-17Open, ClassifiedNonconforming Material/Component
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;
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.
- 2026-04-17Open, ClassifiedNonconforming Material/Component
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
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.
- 2026-04-17Open, ClassifiedNonconforming Material/Component
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;
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.
- 2026-04-17Open, ClassifiedNonconforming Material/Component
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
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.
- 2026-04-17Open, ClassifiedNonconforming Material/Component
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
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.
- 2026-04-17Open, ClassifiedNonconforming Material/Component
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouches;
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.
- 2026-04-17Open, ClassifiedNonconforming Material/Component
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;
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.
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