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TPLC
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Device
tube tracheostomy and tube cuff
Regulation Description
Tracheostomy tube and tube cuff.
Product Code
JOH
Regulation Number
868.5800
Device Class
2
Premarket Reviews
Manufacturer
Decision
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
SMITHS MEDICAL ASD, INC.
SUBSTANTIALLY EQUIVALENT
1
TRACOE MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
791
791
2021
1041
1041
2022
1633
1633
2023
1233
1233
2024
1103
1103
2025
551
551
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
1223
1223
Use of Device Problem
1119
1119
Inflation Problem
876
876
Material Split, Cut or Torn
433
433
Defective Component
415
415
Leak/Splash
286
286
Break
249
249
Disconnection
229
229
Connection Problem
212
212
Material Separation
117
117
Defective Device
112
112
Appropriate Term/Code Not Available
110
110
Fluid/Blood Leak
109
109
Crack
106
106
Insufficient Information
90
90
Material Puncture/Hole
88
88
Fracture
85
85
Physical Resistance/Sticking
78
78
Human-Device Interface Problem
72
72
Obstruction of Flow
60
60
Deflation Problem
58
58
Device Markings/Labelling Problem
54
54
Inadequacy of Device Shape and/or Size
48
48
Material Fragmentation
45
45
Labelling, Instructions for Use or Training Problem
44
44
Material Rupture
43
43
Patient Device Interaction Problem
42
42
Contamination
41
41
Patient-Device Incompatibility
41
41
Material Discolored
40
40
Mechanical Problem
38
38
Material Integrity Problem
38
38
Detachment of Device or Device Component
35
35
Component Missing
35
35
Unintended Deflation
32
32
Material Deformation
31
31
No Apparent Adverse Event
30
30
Difficult to Advance
30
30
Tear, Rip or Hole in Device Packaging
28
28
Product Quality Problem
27
27
Adverse Event Without Identified Device or Use Problem
23
23
Difficult to Insert
23
23
Contamination /Decontamination Problem
22
22
Deformation Due to Compressive Stress
22
22
Material Twisted/Bent
20
20
Device-Device Incompatibility
20
20
Fitting Problem
19
19
Gel Leak
18
18
Loose or Intermittent Connection
18
18
Microbial Contamination of Device
17
17
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3127
3127
Unintended Extubation
1525
1525
Insufficient Information
752
752
No Consequences Or Impact To Patient
450
450
Low Oxygen Saturation
160
160
Extubate
123
123
Hypoventilation
113
113
Decreased Respiratory Rate
82
82
No Patient Involvement
76
76
No Information
68
68
Airway Obstruction
59
59
Unspecified Tissue Injury
58
58
Hemorrhage/Bleeding
57
57
Dyspnea
54
54
Respiratory Insufficiency
50
50
Discomfort
35
35
Tachycardia
25
25
Hypoxia
25
25
Pain
24
24
Skin Inflammation/ Irritation
24
24
Cardiac Arrest
20
20
Distress
19
19
Death
18
18
No Code Available
17
17
Aspiration/Inhalation
17
17
Foreign Body In Patient
15
15
Respiratory Distress
14
14
Respiratory Failure
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
14
14
Unspecified Respiratory Problem
13
13
Inflammation
13
13
Pneumonia
12
12
Cough
11
11
Injury
11
11
Unspecified Infection
11
11
Pneumothorax
11
11
No Known Impact Or Consequence To Patient
10
10
Bradycardia
10
10
Failure of Implant
9
9
Dysphasia
8
8
Respiratory Tract Infection
8
8
Pressure Sores
7
7
Sore Throat
7
7
Obstruction/Occlusion
7
7
High Oxygen Saturation
7
7
Stenosis
6
6
Anxiety
6
6
Ventilator Dependent
6
6
Irritation
6
6
Increased Respiratory Rate
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Incorporated
I
May-10-2023
2
Covidien
I
Mar-25-2025
3
Covidien
I
Apr-19-2023
4
Smiths Medical ASD Inc.
II
Oct-31-2023
5
Smiths Medical ASD Inc.
II
Jul-01-2021
6
Smiths Medical ASD Inc.
II
Feb-23-2021
7
Smiths Medical ASD Inc.
II
Dec-28-2020
8
Smiths Medical ASD Inc.
II
Sep-09-2020
9
Smiths Medical ASD Inc.
II
Jul-01-2020
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