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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
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
2
SMITHS MEDICAL ASD, INC.
SUBSTANTIALLY EQUIVALENT
1
TRACOE MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
1. K203362
TRACOE vario
MDR Year
MDR Reports
MDR Events
2019
1019
1019
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
1209
1209
Use of Device Problem
1078
1078
Inflation Problem
938
938
Leak/Splash
514
514
Material Split, Cut or Torn
433
433
Defective Component
420
420
Break
267
267
Disconnection
228
228
Connection Problem
222
222
Crack
153
153
Material Separation
134
134
Defective Device
126
126
Fluid/Blood Leak
122
122
Material Puncture/Hole
116
116
Appropriate Term/Code Not Available
113
113
Fracture
106
106
Insufficient Information
92
92
Detachment of Device or Device Component
91
91
Physical Resistance/Sticking
84
84
Human-Device Interface Problem
83
83
Inadequacy of Device Shape and/or Size
80
80
Material Discolored
73
73
Obstruction of Flow
67
67
Material Integrity Problem
61
61
Deflation Problem
61
61
Material Rupture
56
56
Device Markings/Labelling Problem
55
55
Material Fragmentation
51
51
Mechanical Problem
49
49
Labelling, Instructions for Use or Training Problem
47
47
Patient Device Interaction Problem
43
43
Patient-Device Incompatibility
43
43
Contamination
39
39
Component Missing
36
36
Material Deformation
32
32
Adverse Event Without Identified Device or Use Problem
32
32
Unintended Deflation
30
30
Product Quality Problem
29
29
Difficult to Advance
28
28
Tear, Rip or Hole in Device Packaging
27
27
Contamination /Decontamination Problem
27
27
Deformation Due to Compressive Stress
24
24
No Apparent Adverse Event
24
24
Difficult to Insert
23
23
Separation Problem
22
22
Material Twisted/Bent
20
20
Gel Leak
20
20
Fitting Problem
20
20
Loose or Intermittent Connection
19
19
Difficult to Remove
19
19
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2828
2828
Unintended Extubation
1423
1423
No Consequences Or Impact To Patient
815
815
Insufficient Information
733
733
Extubate
264
264
No Information
217
217
No Known Impact Or Consequence To Patient
207
207
Low Oxygen Saturation
180
180
No Patient Involvement
147
147
Hypoventilation
114
114
Decreased Respiratory Rate
82
82
Airway Obstruction
64
64
Dyspnea
61
61
Unspecified Tissue Injury
57
57
Hemorrhage/Bleeding
54
54
No Code Available
54
54
Respiratory Insufficiency
48
48
Discomfort
41
41
Respiratory Distress
39
39
Hypoxia
36
36
Pain
33
33
Death
31
31
Tachycardia
26
26
Skin Inflammation/ Irritation
24
24
Inflammation
21
21
Cardiac Arrest
19
19
Distress
16
16
Aspiration/Inhalation
16
16
Irritation
16
16
Respiratory Failure
15
15
Pneumonia
14
14
Unspecified Infection
14
14
Injury
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
14
14
Unspecified Respiratory Problem
13
13
Foreign Body In Patient
13
13
Pneumothorax
12
12
Bradycardia
10
10
Failure of Implant
9
9
Pressure Sores
8
8
Cough
8
8
Respiratory Tract Infection
8
8
Dysphasia
8
8
Increased Respiratory Rate
7
7
High Oxygen Saturation
7
7
Obstruction/Occlusion
7
7
Stenosis
7
7
Anxiety
7
7
Low Blood Pressure/ Hypotension
7
7
Sore Throat
7
7
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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