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TPLC
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Device
prosthesis, tracheal, expandable
Product Code
JCT
Regulation Number
878.3720
Device Class
2
Premarket Reviews
Manufacturer
Decision
M.I. TECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC
SUBSTANTIALLY EQUIVALENT
1
MICRO-TECH (NANJING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2018
122
122
2019
106
106
2020
120
120
2021
106
106
2022
62
62
2023
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
88
88
Material Deformation
71
71
Activation, Positioning or Separation Problem
70
70
Break
59
59
Positioning Problem
56
56
Activation Failure
43
43
Positioning Failure
32
32
Migration
22
22
Appropriate Term/Code Not Available
22
22
Difficult to Remove
19
19
Detachment of Device or Device Component
18
18
Leak/Splash
17
17
Unraveled Material
17
17
Obstruction of Flow
13
13
Failure to Advance
12
12
Fracture
11
11
Use of Device Problem
10
10
Material Rupture
9
9
Material Separation
9
9
Premature Activation
9
9
Defective Device
9
9
Insufficient Information
9
9
Material Integrity Problem
8
8
Material Twisted/Bent
8
8
Device-Device Incompatibility
8
8
Migration or Expulsion of Device
8
8
Difficult to Advance
7
7
Deformation Due to Compressive Stress
7
7
Device Dislodged or Dislocated
7
7
Difficult or Delayed Positioning
6
6
Human-Device Interface Problem
5
5
Expiration Date Error
4
4
Burst Container or Vessel
4
4
Complete Blockage
4
4
Loose or Intermittent Connection
4
4
Mechanical Problem
4
4
Material Puncture/Hole
3
3
Contamination
3
3
Entrapment of Device
3
3
Device Misassembled During Manufacturing /Shipping
3
3
Component Missing
3
3
Packaging Problem
2
2
Difficult to Open or Close
2
2
Separation Failure
2
2
Structural Problem
2
2
Failure to Align
2
2
Failure to Fire
2
2
Fluid/Blood Leak
2
2
Material Fragmentation
2
2
Inflation Problem
2
2
Failure to Capture
2
2
Device Slipped
2
2
Separation Problem
2
2
Premature Separation
2
2
Unclear Information
1
1
Stretched
1
1
Inadequacy of Device Shape and/or Size
1
1
Improper or Incorrect Procedure or Method
1
1
Device Damaged Prior to Use
1
1
Unstable
1
1
Retraction Problem
1
1
Occlusion Within Device
1
1
Unsealed Device Packaging
1
1
Collapse
1
1
Deflation Problem
1
1
Partial Blockage
1
1
Difficult to Insert
1
1
Hole In Material
1
1
Disconnection
1
1
Wrinkled
1
1
Malposition of Device
1
1
Blocked Connection
1
1
Device Operates Differently Than Expected
1
1
Component or Accessory Incompatibility
1
1
Device Markings/Labelling Problem
1
1
Infusion or Flow Problem
1
1
Material Protrusion/Extrusion
1
1
No Apparent Adverse Event
1
1
Material Split, Cut or Torn
1
1
Ejection Problem
1
1
Physical Resistance/Sticking
1
1
Device Fell
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
158
158
No Clinical Signs, Symptoms or Conditions
122
122
Blood Loss
28
28
Death
27
27
No Information
26
26
No Known Impact Or Consequence To Patient
24
24
Thrombosis
23
23
Renal Failure
21
21
Occlusion
19
19
No Code Available
17
17
Hemorrhage/Bleeding
15
15
Obstruction/Occlusion
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
No Patient Involvement
10
10
Ischemia
9
9
Insufficient Information
9
9
Aneurysm
8
8
Dyspnea
7
7
Hematoma
7
7
Vascular Dissection
7
7
Thrombosis/Thrombus
6
6
Restenosis
6
6
Stenosis
5
5
Embolism
5
5
Unspecified Infection
5
5
Inflammation
5
5
Discomfort
4
4
Injury
4
4
Respiratory Failure
4
4
Pseudoaneurysm
4
4
Device Embedded In Tissue or Plaque
4
4
Foreign Body In Patient
4
4
Claudication
3
3
Thrombus
3
3
Pain
3
3
Perforation
3
3
Pneumothorax
3
3
Arrhythmia
3
3
Airway Obstruction
3
3
Calcium Deposits/Calcification
2
2
Granuloma
2
2
Pulmonary Edema
2
2
Respiratory Distress
2
2
Pneumonia
2
2
Hypoxia
2
2
Heart Failure
2
2
Unspecified Kidney or Urinary Problem
2
2
Pericardial Effusion
2
2
Foreign Body Embolism
2
2
Patient Problem/Medical Problem
2
2
Thromboembolism
2
2
Test Result
1
1
Cough
1
1
Respiratory Insufficiency
1
1
Rupture
1
1
Peritonitis
1
1
Disability
1
1
Reaction
1
1
Loss of consciousness
1
1
Respiratory Tract Infection
1
1
Jaundice
1
1
Aortic Dissection
1
1
Ischemic Heart Disease
1
1
Failure of Implant
1
1
Impotence
1
1
Hypersensitivity/Allergic reaction
1
1
Low Blood Pressure/ Hypotension
1
1
Myocardial Infarction
1
1
Nerve Damage
1
1
Internal Organ Perforation
1
1
Abrasion
1
1
Hemoptysis
1
1
Embolus
1
1
Encephalopathy
1
1
Fistula
1
1
Bone Fracture(s)
1
1
Cardiac Arrest
1
1
Stroke/CVA
1
1
Anemia
1
1
Aspiration/Inhalation
1
1
Bradycardia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
I
May-18-2022
2
SPS Sterilization, Inc
II
Sep-13-2018
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