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TPLC
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Device
prosthesis, tracheal, expandable
Regulation Description
Tracheal prosthesis.
Product Code
JCT
Regulation Number
878.3720
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
M.I. TECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MICRO-TECH (NANJING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2020
120
120
2021
106
106
2022
61
61
2023
110
110
2024
77
77
2025
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation, Positioning or Separation Problem
131
131
Material Deformation
90
90
Adverse Event Without Identified Device or Use Problem
59
59
Break
48
48
Positioning Problem
42
42
Positioning Failure
41
41
Activation Failure
39
39
Use of Device Problem
25
25
Migration
24
24
Appropriate Term/Code Not Available
19
19
Material Twisted/Bent
18
18
Failure to Advance
18
18
Defective Device
13
13
Difficult to Remove
12
12
Unraveled Material
12
12
Leak/Splash
12
12
Fracture
12
12
Detachment of Device or Device Component
11
11
Device-Device Incompatibility
9
9
Difficult or Delayed Positioning
9
9
Material Separation
8
8
Difficult to Advance
8
8
Material Rupture
7
7
Malposition of Device
7
7
Material Integrity Problem
6
6
Device Stenosis
6
6
Mechanical Problem
5
5
Insufficient Information
5
5
Premature Activation
5
5
Device Dislodged or Dislocated
5
5
Obstruction of Flow
5
5
Human-Device Interface Problem
4
4
Premature Separation
4
4
Device Misassembled During Manufacturing /Shipping
3
3
Deformation Due to Compressive Stress
3
3
Migration or Expulsion of Device
3
3
Entrapment of Device
2
2
Wrong Label
2
2
Material Puncture/Hole
2
2
Unsealed Device Packaging
2
2
Separation Problem
2
2
Complete Blockage
2
2
Difficult to Open or Close
2
2
Expiration Date Error
2
2
No Apparent Adverse Event
2
2
Material Fragmentation
2
2
Packaging Problem
2
2
Off-Label Use
2
2
Separation Failure
2
2
Device Damaged Prior to Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
275
275
No Consequences Or Impact To Patient
67
67
Obstruction/Occlusion
17
17
Hemorrhage/Bleeding
14
14
Insufficient Information
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Blood Loss
10
10
Death
9
9
Occlusion
8
8
No Information
8
8
Stenosis of the esophagus
6
6
Thrombosis/Thrombus
6
6
Restenosis
6
6
Renal Failure
6
6
Perforation
5
5
No Code Available
5
5
Stenosis
5
5
Thrombosis
5
5
Aneurysm
5
5
Dyspnea
5
5
Unspecified Infection
4
4
Hypoxia
4
4
Ischemia
4
4
Embolism
4
4
No Known Impact Or Consequence To Patient
4
4
Discomfort
4
4
Inflammation
3
3
Foreign Body Embolism
3
3
Respiratory Insufficiency
3
3
Pneumothorax
3
3
Device Embedded In Tissue or Plaque
3
3
Erosion
2
2
Vascular Dissection
2
2
Pseudoaneurysm
2
2
No Patient Involvement
2
2
Claudication
2
2
Calcium Deposits/Calcification
2
2
Thromboembolism
2
2
Unspecified Kidney or Urinary Problem
2
2
Hematoma
2
2
Injury
2
2
Foreign Body In Patient
2
2
Cardiac Arrest
2
2
Hypersensitivity/Allergic reaction
1
1
Airway Obstruction
1
1
Pulmonary Edema
1
1
Pneumonia
1
1
Low Blood Pressure/ Hypotension
1
1
Anemia
1
1
Heart Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
I
May-18-2022
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