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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
144
144
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
1144
1144
Use of Device Problem
999
999
Inflation Problem
822
822
Defective Component
397
397
Material Split, Cut or Torn
391
391
Leak/Splash
284
284
Break
223
223
Connection Problem
210
210
Disconnection
187
187
Defective Device
112
112
Material Separation
110
110
Appropriate Term/Code Not Available
107
107
Fluid/Blood Leak
103
103
Crack
94
94
Material Puncture/Hole
87
87
Fracture
82
82
Insufficient Information
81
81
Physical Resistance/Sticking
70
70
Human-Device Interface Problem
70
70
Obstruction of Flow
58
58
Device Markings/Labelling Problem
51
51
Deflation Problem
50
50
Inadequacy of Device Shape and/or Size
47
47
Material Fragmentation
45
45
Labelling, Instructions for Use or Training Problem
43
43
Material Rupture
42
42
Patient Device Interaction Problem
41
41
Material Discolored
37
37
Patient-Device Incompatibility
37
37
Contamination
37
37
Detachment of Device or Device Component
35
35
Material Integrity Problem
35
35
Mechanical Problem
35
35
Component Missing
31
31
Material Deformation
30
30
Unintended Deflation
30
30
Difficult to Advance
28
28
Tear, Rip or Hole in Device Packaging
27
27
Product Quality Problem
26
26
No Apparent Adverse Event
24
24
Adverse Event Without Identified Device or Use Problem
23
23
Deformation Due to Compressive Stress
22
22
Difficult to Insert
22
22
Contamination /Decontamination Problem
21
21
Material Twisted/Bent
19
19
Fitting Problem
19
19
Gel Leak
18
18
Device-Device Incompatibility
18
18
Loose or Intermittent Connection
17
17
Microbial Contamination of Device
17
17
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2823
2823
Unintended Extubation
1423
1423
Insufficient Information
733
733
No Consequences Or Impact To Patient
450
450
Low Oxygen Saturation
158
158
Extubate
123
123
Hypoventilation
112
112
Decreased Respiratory Rate
82
82
No Patient Involvement
76
76
No Information
68
68
Airway Obstruction
59
59
Unspecified Tissue Injury
56
56
Hemorrhage/Bleeding
52
52
Dyspnea
51
51
Respiratory Insufficiency
48
48
Discomfort
35
35
Tachycardia
25
25
Skin Inflammation/ Irritation
24
24
Pain
24
24
Hypoxia
24
24
Cardiac Arrest
19
19
Death
18
18
No Code Available
17
17
Distress
15
15
Aspiration/Inhalation
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
Foreign Body In Patient
13
13
Pneumonia
12
12
Inflammation
12
12
Injury
11
11
Unspecified Infection
11
11
Bradycardia
10
10
No Known Impact Or Consequence To Patient
10
10
Pneumothorax
10
10
Failure of Implant
9
9
Respiratory Tract Infection
8
8
Dysphasia
8
8
Cough
8
8
Obstruction/Occlusion
7
7
High Oxygen Saturation
7
7
Pressure Sores
7
7
Sore Throat
7
7
Low Blood Pressure/ Hypotension
6
6
Anxiety
6
6
Bacterial Infection
6
6
Stenosis
6
6
Irritation
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Incorporated
I
May-10-2023
2
Covidien
I
Apr-19-2023
3
Smiths Medical ASD Inc.
II
Oct-31-2023
4
Smiths Medical ASD Inc.
II
Jul-01-2021
5
Smiths Medical ASD Inc.
II
Feb-23-2021
6
Smiths Medical ASD Inc.
II
Dec-28-2020
7
Smiths Medical ASD Inc.
II
Sep-09-2020
8
Smiths Medical ASD Inc.
II
Jul-01-2020
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