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TPLC
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Device
catheter, intravascular, diagnostic
Product Code
DQO
Regulation Number
870.1200
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT MEDICAL
SUBSTANTIALLY EQUIVALENT
3
ACCURATE MEDICAL THERAPEUTICS
SUBSTANTIALLY EQUIVALENT
1
1. K203487
Drakon and Sequre Microcatheters
ACCURATE MEDICAL THERAPEUTICS LTD
SUBSTANTIALLY EQUIVALENT
1
1. K203487
Drakon and Sequre Microcatheters
ACCURATE MEDICAL THERAPEUTICS LTD.
SUBSTANTIALLY EQUIVALENT
1
BEND IT TECHNOLOGIES LTD
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
CORDIS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
CORDIS US CORP.
SUBSTANTIALLY EQUIVALENT
1
EMBOLX, INC.
SUBSTANTIALLY EQUIVALENT
1
GENTUITY, LLC
SUBSTANTIALLY EQUIVALENT
1
IMPERATIVE CARE, INC.
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
PFM MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
PHENOX LTD
SUBSTANTIALLY EQUIVALENT
1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
STRYKER
SUBSTANTIALLY EQUIVALENT
1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
TERUMO CLINICAL SUPPLY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
VASCULAR SOLUTIONS LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
385
385
2020
312
312
2021
337
337
2022
379
379
2023
385
385
2024
114
114
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
528
528
Fracture
524
524
Detachment of Device or Device Component
270
270
Adverse Event Without Identified Device or Use Problem
174
174
Difficult to Remove
138
138
Break
130
130
Crack
63
63
Difficult to Advance
52
52
Material Puncture/Hole
51
51
Device Contamination with Chemical or Other Material
33
33
Material Deformation
32
32
Material Split, Cut or Torn
32
32
Fluid/Blood Leak
30
30
Entrapment of Device
28
28
Device Contaminated During Manufacture or Shipping
28
28
Device-Device Incompatibility
27
27
Material Integrity Problem
26
26
Failure to Advance
26
26
Material Twisted/Bent
24
24
Difficult to Insert
22
22
Failure to Align
22
22
Physical Resistance/Sticking
21
21
Incorrect, Inadequate or Imprecise Result or Readings
20
20
Leak/Splash
19
19
Deformation Due to Compressive Stress
18
18
Communication or Transmission Problem
17
17
Material Rupture
17
17
Unable to Obtain Readings
16
16
Tear, Rip or Hole in Device Packaging
16
16
Gas/Air Leak
15
15
Separation Problem
15
15
Peeled/Delaminated
13
13
Material Fragmentation
13
13
No Display/Image
12
12
Delivered as Unsterile Product
12
12
Material Frayed
9
9
Use of Device Problem
9
9
Defective Device
9
9
Stretched
8
8
Positioning Problem
8
8
Structural Problem
8
8
Obstruction of Flow
7
7
Contamination /Decontamination Problem
7
7
Burst Container or Vessel
7
7
Migration
7
7
Improper or Incorrect Procedure or Method
7
7
Device Damaged by Another Device
7
7
Poor Quality Image
7
7
Unraveled Material
6
6
Component Misassembled
6
6
Therapeutic or Diagnostic Output Failure
6
6
Deflation Problem
5
5
Partial Blockage
5
5
Unsealed Device Packaging
5
5
Material Too Soft/Flexible
5
5
Disconnection
4
4
Complete Blockage
4
4
Air/Gas in Device
4
4
Difficult to Flush
4
4
Activation, Positioning or Separation Problem
4
4
Device Dislodged or Dislocated
3
3
No Apparent Adverse Event
3
3
Connection Problem
3
3
Contamination
3
3
Failure to Sense
3
3
Inflation Problem
3
3
Unintended Movement
3
3
Material Protrusion/Extrusion
3
3
Separation Failure
3
3
Flushing Problem
3
3
Packaging Problem
3
3
Calibration Problem
3
3
Mechanical Problem
2
2
Insufficient Information
2
2
Output Problem
2
2
Difficult to Open or Remove Packaging Material
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Device Damaged Prior to Use
2
2
Device Markings/Labelling Problem
2
2
High Test Results
2
2
Activation Failure
2
2
Difficult or Delayed Positioning
2
2
Activation Problem
2
2
Device Difficult to Setup or Prepare
2
2
Loss of or Failure to Bond
2
2
Appropriate Term/Code Not Available
2
2
Component Missing
2
2
Particulates
2
2
Melted
1
1
Retraction Problem
1
1
Device Displays Incorrect Message
1
1
Output above Specifications
1
1
Migration or Expulsion of Device
1
1
Defective Component
1
1
Material Discolored
1
1
Product Quality Problem
1
1
Unexpected Therapeutic Results
1
1
Vibration
1
1
Device Alarm System
1
1
Flaked
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
906
906
Foreign Body In Patient
232
232
No Consequences Or Impact To Patient
230
230
No Known Impact Or Consequence To Patient
96
96
Vascular Dissection
89
89
No Patient Involvement
68
68
Insufficient Information
50
50
Device Embedded In Tissue or Plaque
45
45
Perforation of Vessels
44
44
No Code Available
35
35
Cardiac Arrest
18
18
Occlusion
18
18
Thrombosis/Thrombus
17
17
Death
16
16
Stroke/CVA
14
14
Thrombosis
13
13
Perforation
13
13
Low Blood Pressure/ Hypotension
12
12
No Information
11
11
Hemorrhage/Bleeding
11
11
Vasoconstriction
10
10
Obstruction/Occlusion
9
9
Rupture
8
8
Chest Pain
8
8
Coagulation Disorder
8
8
Cardiac Perforation
8
8
Pericardial Effusion
6
6
Pulmonary Embolism
6
6
Blood Loss
6
6
Hematoma
6
6
Dyspnea
5
5
Pain
5
5
Ventricular Fibrillation
5
5
Cardiogenic Shock
5
5
Air Embolism
5
5
Intracranial Hemorrhage
5
5
Paresis
4
4
Muscle Spasm(s)
4
4
Vascular System (Circulation), Impaired
4
4
Internal Organ Perforation
4
4
Arrhythmia
4
4
Coma
4
4
Ischemia
4
4
Vessel Or Plaque, Device Embedded In
4
4
Cardiac Tamponade
4
4
Injury
4
4
Embolus
4
4
Embolism
4
4
Renal Failure
4
4
Myocardial Infarction
4
4
Intimal Dissection
3
3
Thromboembolism
3
3
Pseudoaneurysm
3
3
Calcium Deposits/Calcification
3
3
Encephalopathy
3
3
Thrombus
3
3
Muscle Weakness
3
3
Ischemia Stroke
3
3
Angina
3
3
Brain Injury
3
3
Bradycardia
3
3
Respiratory Arrest
2
2
Unspecified Tissue Injury
2
2
Hemoptysis
2
2
Not Applicable
2
2
Swelling
2
2
Embolism/Embolus
2
2
Inflammation
2
2
Hemorrhage, Cerebral
2
2
Tachycardia
2
2
Stenosis
2
2
Laceration(s)
2
2
Failure of Implant
2
2
Foreign Body Embolism
2
2
Non specific EKG/ECG Changes
2
2
Memory Loss/Impairment
2
2
High Blood Pressure/ Hypertension
2
2
Paralysis
2
2
Headache
2
2
Loss of Vision
2
2
Speech Disorder
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Atrial Perforation
2
2
Transient Ischemic Attack
1
1
Loss of consciousness
1
1
Pulmonary Edema
1
1
Infarction, Cerebral
1
1
Bacterial Infection
1
1
Patient Problem/Medical Problem
1
1
Discomfort
1
1
Fistula
1
1
Hemorrhage, Subarachnoid
1
1
Dizziness
1
1
Atrial Fibrillation
1
1
Unspecified Infection
1
1
Aortic Valve Stenosis
1
1
Infiltration into Tissue
1
1
Emotional Changes
1
1
Paresthesia
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Vascular
I
May-19-2022
2
Boston Scientific Corporation
I
Mar-25-2020
3
Cook Inc.
II
Nov-18-2019
4
Cordis Corporation
I
Sep-15-2021
5
Cordis US Corp
I
Nov-09-2023
6
Cordis US Corp
II
Dec-16-2022
7
Stryker Neurovascular
II
Jul-15-2022
8
Stryker, Inc.
II
Feb-14-2024
9
Vascular Solutions, Inc.
I
Oct-20-2020
10
Vascular Solutions, Inc.
I
Apr-27-2020
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