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TPLC
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Device
low energy direct current thermal ablation system
Definition
Ablation of soft tissue
Product Code
OAB
Regulation Number
878.4400
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANGIODYNAMICS
SUBSTANTIALLY EQUIVALENT
1
GALVANIZE THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
5
5
2019
6
6
2020
16
16
2021
11
11
2022
4
4
2023
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
26
26
Communication or Transmission Problem
7
7
Arcing of Electrodes
4
4
Device Remains Activated
3
3
Unexpected Shutdown
3
3
Output Problem
2
2
Charging Problem
2
2
Firing Problem
2
2
Power Problem
2
2
Pacing Problem
2
2
Computer Software Problem
2
2
Material Discolored
2
2
No Display/Image
2
2
Failure to Deliver Energy
2
2
Melted
2
2
Energy Output Problem
2
2
Failure to Fire
2
2
Device Sensing Problem
2
2
Failure of Device to Self-Test
2
2
Failure to Auto Stop
1
1
Failure to Shut Off
1
1
Infusion or Flow Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
No Flow
1
1
Difficult to Advance
1
1
Difficult to Open or Remove Packaging Material
1
1
Expulsion
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Detachment of Device or Device Component
1
1
Device Markings/Labelling Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Battery Problem
1
1
Calibration Problem
1
1
Output above Specifications
1
1
Migration or Expulsion of Device
1
1
Poor Quality Image
1
1
Delivered as Unsterile Product
1
1
Material Opacification
1
1
Incomplete or Missing Packaging
1
1
Failure to Deliver
1
1
Failure to Infuse
1
1
Tear, Rip or Hole in Device Packaging
1
1
Dull, Blunt
1
1
Obstruction of Flow
1
1
Failure to Calibrate
1
1
Failure to Advance
1
1
Misfire
1
1
Low Sensing Threshold
1
1
Arcing
1
1
Delayed Charge Time
1
1
Device Displays Incorrect Message
1
1
Sparking
1
1
Flaked
1
1
Fluid/Blood Leak
1
1
Fracture
1
1
Material Fragmentation
1
1
Material Frayed
1
1
Labelling, Instructions for Use or Training Problem
1
1
Inability to Irrigate
1
1
Leak/Splash
1
1
Mechanical Problem
1
1
Display or Visual Feedback Problem
1
1
Continuous Firing
1
1
Crack
1
1
Arcing at Paddles
1
1
Loss of or Failure to Bond
1
1
Break
1
1
Failure to Charge
1
1
Unsealed Device Packaging
1
1
Pitted
1
1
Failure to Power Up
1
1
Off-Label Use
1
1
Decreased Pump Speed
1
1
Increased Pump Speed
1
1
Failure to Pump
1
1
Pumping Stopped
1
1
Material Puncture/Hole
1
1
Difficult to Remove
1
1
Shipping Damage or Problem
1
1
Device Stops Intermittently
1
1
Stretched
1
1
Inaccurate Synchronization
1
1
Unexpected Therapeutic Results
1
1
Use of Device Problem
1
1
Insufficient Flow or Under Infusion
1
1
Material Perforation
1
1
Visual Prompts will not Clear
1
1
Device Damaged Prior to Use
1
1
Aborted Charge
1
1
Pumping Problem
1
1
Temperature Problem
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Device Handling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
12
12
No Known Impact Or Consequence To Patient
9
9
Thrombosis/Thrombus
5
5
Patient Problem/Medical Problem
4
4
Tissue Breakdown
3
3
Obstruction/Occlusion
2
2
Atrial Fibrillation
2
2
Fistula
2
2
Tachycardia
2
2
No Consequences Or Impact To Patient
2
2
Ulcer
1
1
Aneurysm
1
1
Arrhythmia
1
1
Tissue Damage
1
1
Ventricular Fibrillation
1
1
Perforation of Vessels
1
1
Hemorrhage/Bleeding
1
1
Necrosis
1
1
Internal Organ Perforation
1
1
Pain
1
1
Paresis
1
1
Bacterial Infection
1
1
Bradycardia
1
1
Burn(s)
1
1
Fluid Discharge
1
1
Heart Failure/Congestive Heart Failure
1
1
Movement Disorder
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Angiodynamics, Inc.
II
Apr-12-2023
2
Angiodynamics, Inc.
II
Oct-07-2021
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