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TPLC
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Device
tubes, gastrointestinal (and accessories)
Product Code
KNT
Regulation Number
876.5980
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACTUATED MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
APPLIED MEDICAL TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
2
SUBSTANTIALLY EQUIVALENT - KIT
2
ASPIRE BARIATRICS, INC
SUBSTANTIALLY EQUIVALENT
1
ASPIRE BARIATRICS, INC.
SUBSTANTIALLY EQUIVALENT
1
AVANOS MEDICAL INC
SUBSTANTIALLY EQUIVALENT
1
AVANOS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
BIONIX DEVELOPMENT CORPORATION
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
CM TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
CONVATEC LIMITED
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
CREATIVE BALLOONS GMBH
SUBSTANTIALLY EQUIVALENT
1
DENTSPLY SIRONA
SUBSTANTIALLY EQUIVALENT
1
ENDOLUMIK INC.
SUBSTANTIALLY EQUIVALENT
1
ENVIZION MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
3
GRAVITAS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
HALYARD HEALTH, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
MEDCAPTAIN LIFE SCIENCE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
NASER DIB GABINET LEKARKSI NASMED
SUBSTANTIALLY EQUIVALENT
1
NASOGASTRIC FEEDING SOLUTIONS, LTD.
SUBSTANTIALLY EQUIVALENT
1
PROSYS INTERNATIONAL LTD
SUBSTANTIALLY EQUIVALENT
1
RESHAPE LIFESCIENCES
SUBSTANTIALLY EQUIVALENT
3
STANDARD BARIATRICS
SUBSTANTIALLY EQUIVALENT
3
STANDARD BARIATRICS, INC.
SUBSTANTIALLY EQUIVALENT
1
TOOLS FOR SURGERY, LLC
SUBSTANTIALLY EQUIVALENT
1
WILSON-COOK MEDICAL, INC
SUBSTANTIALLY EQUIVALENT - KIT
2
MDR Year
MDR Reports
MDR Events
2018
1899
1899
2019
1837
1837
2020
1641
1641
2021
1652
1652
2022
1650
1650
2023
1340
1340
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
5354
5354
Fluid/Blood Leak
719
719
Detachment of Device or Device Component
597
597
Break
574
574
Leak/Splash
339
339
Difficult to Remove
241
241
Malposition of Device
215
215
Device Dislodged or Dislocated
180
180
Material Rupture
174
174
Obstruction of Flow
169
169
Deflation Problem
157
157
Material Twisted/Bent
152
152
Material Split, Cut or Torn
118
118
Material Puncture/Hole
103
103
Disconnection
95
95
Migration
92
92
Crack
90
90
Fracture
80
80
Material Separation
76
76
Insufficient Information
71
71
Unintended Deflation
68
68
Burst Container or Vessel
66
66
Inflation Problem
65
65
Detachment Of Device Component
64
64
Complete Blockage
63
63
Material Integrity Problem
58
58
Migration or Expulsion of Device
57
57
Patient Device Interaction Problem
56
56
Use of Device Problem
46
46
No Apparent Adverse Event
39
39
Improper or Incorrect Procedure or Method
38
38
Component Missing
38
38
Patient-Device Incompatibility
37
37
Material Fragmentation
36
36
Appropriate Term/Code Not Available
36
36
Device Handling Problem
33
33
Device Contamination with Chemical or Other Material
33
33
Physical Resistance/Sticking
31
31
Kinked
30
30
Defective Component
30
30
Defective Device
27
27
Difficult to Advance
25
25
Biocompatibility
25
25
Material Perforation
25
25
Fitting Problem
23
23
Entrapment of Device
23
23
Material Deformation
22
22
Positioning Problem
20
20
Pressure Problem
19
19
Loose or Intermittent Connection
19
19
Partial Blockage
18
18
Product Quality Problem
17
17
Nonstandard Device
16
16
Occlusion Within Device
16
16
Decrease in Pressure
16
16
Separation Failure
15
15
Device Fell
15
15
Device Markings/Labelling Problem
14
14
Device Operates Differently Than Expected
14
14
Degraded
13
13
Therapeutic or Diagnostic Output Failure
13
13
Misconnection
12
12
Stretched
12
12
Hole In Material
11
11
Positioning Failure
11
11
Material Frayed
10
10
Material Too Rigid or Stiff
10
10
Difficult to Open or Close
10
10
Device Displays Incorrect Message
10
10
Deformation Due to Compressive Stress
10
10
Human-Device Interface Problem
10
10
Difficult or Delayed Separation
9
9
Difficult to Flush
9
9
Inability to Irrigate
9
9
No Display/Image
8
8
Off-Label Use
8
8
Incorrect, Inadequate or Imprecise Result or Readings
8
8
Suction Problem
8
8
Gas/Air Leak
8
8
No Flow
8
8
Unintended Movement
7
7
Expulsion
7
7
Manufacturing, Packaging or Shipping Problem
7
7
Air/Gas in Device
7
7
Separation Problem
7
7
Volume Accuracy Problem
7
7
Device Slipped
7
7
Display or Visual Feedback Problem
7
7
Contamination
6
6
Mechanical Problem
6
6
Flushing Problem
6
6
Collapse
6
6
Difficult to Insert
6
6
Inadequacy of Device Shape and/or Size
6
6
Unexpected Therapeutic Results
6
6
Contamination /Decontamination Problem
6
6
Connection Problem
6
6
Failure to Advance
6
6
Device Contaminated During Manufacture or Shipping
6
6
Torn Material
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
1410
1410
Skin Infection
1320
1320
No Clinical Signs, Symptoms or Conditions
1248
1248
No Consequences Or Impact To Patient
1111
1111
No Code Available
789
789
No Known Impact Or Consequence To Patient
764
764
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
728
728
Post Operative Wound Infection
352
352
Foreign Body In Patient
300
300
Insufficient Information
291
291
Ulcer
270
270
Peritonitis
214
214
Pneumothorax
196
196
Bowel Perforation
165
165
No Patient Involvement
159
159
Hemorrhage/Bleeding
155
155
Death
151
151
Pneumonia
129
129
Perforation
110
110
Abscess
93
93
Pain
82
82
Aspiration/Inhalation
79
79
No Information
79
79
Stomach Ulceration
73
73
Sepsis
71
71
Pressure Sores
70
70
Tissue Breakdown
60
60
Obstruction/Occlusion
50
50
Discomfort
48
48
Aspiration Pneumonitis
47
47
Device Embedded In Tissue or Plaque
45
45
Abdominal Pain
45
45
Vomiting
43
43
Inflammation
40
40
Laceration(s)
38
38
Gastrointestinal Hemorrhage
37
37
Skin Inflammation/ Irritation
28
28
Blood Loss
27
27
Fistula
27
27
Internal Organ Perforation
27
28
Necrosis
26
26
Injury
26
26
Tissue Damage
23
23
Ulceration
23
23
Cellulitis
22
22
Fluid Discharge
22
22
Patient Problem/Medical Problem
21
21
Needle Stick/Puncture
21
21
Granuloma
21
21
Failure of Implant
21
21
Low Oxygen Saturation
20
20
Skin Tears
19
19
Cardiac Arrest
19
19
Anemia
18
18
Perforation of Esophagus
18
18
Bacterial Infection
17
17
Erosion
16
16
Nausea
15
15
Burn(s)
14
14
Fever
14
14
Erythema
14
14
Feeding Problem
13
13
Skin Irritation
13
13
Respiratory Failure
13
13
Abdominal Distention
13
13
Unspecified Tissue Injury
13
13
Respiratory Distress
12
12
Gastritis
12
12
Low Blood Pressure/ Hypotension
12
12
Skin Erosion
11
11
Laceration(s) of Esophagus
10
10
Tachycardia
10
10
Diarrhea
10
10
Dyspnea
9
9
Hematoma
9
9
Hypoglycemia
9
9
Hypoxia
9
9
Pleural Effusion
9
9
Pulmonary Embolism
8
8
Fungal Infection
7
7
Swelling/ Edema
7
7
Weight Changes
6
6
Skin Inflammation
5
5
Unintended Extubation
5
5
Cough
5
5
Rupture
5
5
Septic Shock
5
5
Shock
4
4
Skin Discoloration
4
4
Purulent Discharge
4
4
Exposure to Body Fluids
4
4
Adult Respiratory Distress Syndrome
4
4
Hypersensitivity/Allergic reaction
4
4
Headache
4
4
Hemothorax
3
3
Cardiopulmonary Arrest
3
3
Ischemia
3
3
Itching Sensation
3
3
Airway Obstruction
3
3
Adhesion(s)
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Avanos Medical, Inc.
I
May-13-2022
2
Avanos Medical, Inc.
II
Feb-07-2022
3
Avanos Medical, Inc.
II
Dec-07-2020
4
Avanos Medical, Inc.
II
Sep-17-2020
5
Avanos Medical, Inc.
II
Nov-14-2019
6
COVIDIEN LLC
II
Dec-11-2018
7
Cook Inc.
II
Mar-01-2018
8
Covidien LLC
II
Feb-20-2018
9
Hollister Incorporated
II
Mar-26-2021
10
Neomed Inc
III
Nov-30-2018
11
Teleflex Medical Europe Ltd
II
Apr-12-2018
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