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TPLC
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Device
injector and syringe, angiographic
Product Code
DXT
Regulation Number
870.1650
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACIST MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
3
BAYER MEDICAL CARE INC.
SUBSTANTIALLY EQUIVALENT
4
BAYER MEDICAL CARE, INC.
SUBSTANTIALLY EQUIVALENT
1
COEUR, INC.
SUBSTANTIALLY EQUIVALENT
2
DEROYAL INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
ECOMED SOLUTIONS, LLC
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
SUBSTANTIALLY EQUIVALENT - KIT
1
NEMOTO KYORINDO CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NINGBO DIZENGENS MEDICAL SCIENCE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OSPREY MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
OSPREY MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
7
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
SUBSTANTIALLY EQUIVALENT
2
SHENYANG MASTECH MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD
SUBSTANTIALLY EQUIVALENT
2
SHENZHEN BOON MEDICAL SUPPLY CO., LTD
SUBSTANTIALLY EQUIVALENT
2
SUNNY MEDICAL DEVICE (SHENZHEN) CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
UNION MEDICAL SHENZHEN CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
SUBSTANTIALLY EQUIVALENT
1
YOUWO (GUANGZHOU) MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
152
152
2017
128
128
2018
129
129
2019
121
121
2020
93
93
2021
132
132
2022
111
114
2023
117
117
2024
31
31
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
274
274
Device Contamination with Chemical or Other Material
67
67
Insufficient Information
55
55
Manufacturing, Packaging or Shipping Problem
52
52
Break
45
45
Air Leak
45
45
Detachment of Device or Device Component
37
37
Device Operates Differently Than Expected
36
36
Inflation Problem
26
26
Material Integrity Problem
22
22
Defective Device
22
22
Fluid/Blood Leak
20
23
Contamination /Decontamination Problem
19
19
Use of Device Problem
19
19
Smoking
19
19
Product Quality Problem
18
18
Gas/Air Leak
18
18
Leak/Splash
18
18
Improper or Incorrect Procedure or Method
17
17
Activation Problem
17
17
Mechanical Problem
12
12
Device Contaminated During Manufacture or Shipping
11
11
Air/Gas in Device
10
10
Device Displays Incorrect Message
10
10
Self-Activation or Keying
8
8
Particulates
8
8
Output Problem
8
8
Nonstandard Device
8
8
Device Dislodged or Dislocated
7
7
Therapeutic or Diagnostic Output Failure
7
7
Appropriate Term/Code Not Available
7
7
Material Disintegration
7
7
Patient-Device Incompatibility
6
6
Inaccurate Delivery
6
6
Crack
6
6
Thermal Decomposition of Device
5
5
Disconnection
5
5
Separation Failure
5
5
Defective Component
5
5
Failure to Deliver
5
5
Deflation Problem
5
5
No Apparent Adverse Event
5
5
Electrical /Electronic Property Problem
5
5
Connection Problem
4
4
Component Missing
4
4
Fire
4
4
Sparking
4
4
Failure to Power Up
4
4
Unsealed Device Packaging
4
4
Loose or Intermittent Connection
4
4
Improper Flow or Infusion
4
4
Display or Visual Feedback Problem
4
4
Noise, Audible
4
4
Device Alarm System
3
3
Component Falling
3
3
Entrapment of Device
3
3
Material Separation
3
3
Device Handling Problem
3
3
Excess Flow or Over-Infusion
3
3
Protective Measures Problem
3
3
Pressure Problem
3
3
Physical Resistance/Sticking
3
3
Detachment Of Device Component
3
3
Communication or Transmission Problem
3
3
Improper Device Output
3
3
Device Inoperable
3
3
Unexpected Therapeutic Results
3
3
Contamination
3
3
No Display/Image
3
3
Material Puncture/Hole
3
3
Physical Property Issue
3
3
Material Split, Cut or Torn
2
2
Loss of or Failure to Bond
2
2
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
2
2
Device Difficult to Setup or Prepare
2
2
Unintended System Motion
2
2
Backflow
2
2
Application Program Problem: Dose Calculation Error
2
2
Explosion
2
2
Device Fell
2
2
Inappropriate/Inadequate Shock/Stimulation
2
2
Material Twisted/Bent
2
2
Human-Device Interface Problem
2
2
Fracture
2
2
Bent
2
2
Unintended Electrical Shock
2
2
Sticking
2
2
Partial Blockage
2
2
Loss of Power
2
2
Unexpected Shutdown
2
2
Device Issue
2
2
Device Emits Odor
2
2
Failure to Disconnect
2
2
Device Markings/Labelling Problem
2
2
Premature Activation
2
2
Device Slipped
1
1
Inadequate User Interface
1
1
Calibration Problem
1
1
Electrical Overstress
1
1
Temperature Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Air Embolism
198
199
No Clinical Signs, Symptoms or Conditions
192
195
No Known Impact Or Consequence To Patient
170
170
No Patient Involvement
87
87
No Consequences Or Impact To Patient
64
64
Insufficient Information
52
52
Cardiac Arrest
48
48
Extravasation
43
43
Not Applicable
31
31
Death
28
28
No Information
22
22
Vascular Dissection
22
22
Low Blood Pressure/ Hypotension
14
14
No Code Available
13
13
Respiratory Failure
10
10
Patient Problem/Medical Problem
8
8
Embolism
8
8
Chest Pain
8
8
Pain
8
8
Ventricular Fibrillation
7
7
Infiltration into Tissue
7
7
Bradycardia
6
6
Chemical Exposure
6
6
Respiratory Arrest
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Electric Shock
5
5
Swelling
5
5
Overdose
4
4
Myocardial Infarction
4
4
Embolism/Embolus
4
4
Nausea
3
3
Bone Fracture(s)
3
3
Non specific EKG/ECG Changes
3
3
Edema
3
3
Angina
3
3
Hypersensitivity/Allergic reaction
3
3
Respiratory Distress
3
3
Complaint, Ill-Defined
3
3
Injury
3
3
Reaction
3
3
Loss of consciousness
2
2
Diaphoresis
2
2
Malaise
2
2
Brain Injury
2
2
Arrhythmia
2
2
Aneurysm
2
2
Pulmonary Embolism
2
2
Abdominal Pain
2
2
Dyspnea
2
2
Cardiopulmonary Arrest
2
2
Stroke/CVA
2
2
Unspecified Tissue Injury
2
2
Loss Of Pulse
2
2
Dizziness
2
2
Missing Value Reason
2
2
Ischemia Stroke
2
2
Thromboembolism
1
1
Foreign Body In Patient
1
1
Blood Loss
1
1
Diminished Pulse Pressure
1
1
Aortic Dissection
1
1
Ischemic Heart Disease
1
1
Suture Abrasion
1
1
Underdose
1
1
Swelling/ Edema
1
1
Renal Impairment
1
1
Abrasion
1
1
Atherosclerosis
1
1
Atrial Fibrillation
1
1
Apnea
1
1
Gangrene
1
1
Head Injury
1
1
Headache
1
1
Hepatitis
1
1
Eye Injury
1
1
Fall
1
1
Foreign Body Reaction
1
1
Inflammation
1
1
Ischemia
1
1
Embolus
1
1
Unspecified Infection
1
1
Cardiac Tamponade
1
1
Discomfort
1
1
Rupture
1
1
Ventilator Dependent
1
1
Chest Tightness/Pressure
1
1
Pallor
1
1
Low Oxygen Saturation
1
1
Obstruction/Occlusion
1
1
Numbness
1
1
ST Segment Elevation
1
1
Seizures, Focal Motor
1
1
Shock
1
1
Perforation
1
1
Pneumonia
1
1
Loss of Range of Motion
1
1
Transient Ischemic Attack
1
1
Vasoconstriction
1
1
Visual Impairment
1
1
Vomiting
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Acist Medical Systems
II
Feb-02-2016
2
B. Braun Medical, Inc.
II
Nov-03-2023
3
Bayer Healthcare
II
Sep-08-2016
4
Bayer Healthcare
II
Jul-19-2016
5
Bayer Medical Care, Inc.
II
Nov-03-2021
6
Bayer Medical Care, Inc.
II
Nov-23-2020
7
Bayer Medical Care, Inc.
II
Jan-15-2019
8
Bracco Injeneering S.A.
II
Dec-21-2018
9
LeMaitre Vascular, Inc.
II
May-04-2021
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