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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
implant, intragastric for morbid obesity
Product Code
LTI
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
4
7
10
1
2
3
6
14
14
32
21
5
3
2
4
4
MDR Year
MDR Reports
MDR Events
2014
563
563
2015
556
556
2016
514
514
2017
528
528
2018
453
453
2019
334
334
2020
165
165
2021
193
193
2022
609
609
2023
975
975
2024
325
325
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
1159
1159
Adverse Event Without Identified Device or Use Problem
868
868
Insufficient Information
851
851
Deflation Problem
652
652
Device Slipped
405
405
Patient-Device Incompatibility
236
236
Leak/Splash
195
195
Unintended Deflation
185
185
Migration or Expulsion of Device
160
160
Free or Unrestricted Flow
158
158
Inflation Problem
121
121
Air/Gas in Device
91
91
Migration
88
88
Material Erosion
87
87
Appropriate Term/Code Not Available
86
86
Use of Device Problem
61
61
Device Operates Differently Than Expected
57
57
Break
52
52
No Apparent Adverse Event
46
46
Detachment of Device or Device Component
41
41
Disconnection
31
31
Device Issue
24
24
Material Separation
23
23
Patient Device Interaction Problem
23
23
Obstruction of Flow
18
18
Fracture
18
18
Detachment Of Device Component
15
15
Malposition of Device
14
14
Device Dislodged or Dislocated
14
14
Mechanical Problem
13
13
Improper or Incorrect Procedure or Method
13
13
Unintended Movement
12
12
Inadequacy of Device Shape and/or Size
12
12
Difficult to Remove
12
12
Extrusion
11
11
Material Integrity Problem
10
10
Therapeutic or Diagnostic Output Failure
8
8
Defective Device
8
8
Output Problem
7
7
Filling Problem
7
7
Material Rupture
7
7
Burst Container or Vessel
7
7
Device Inoperable
7
7
Entrapment of Device
6
6
Material Twisted/Bent
6
6
Infusion or Flow Problem
6
6
Nonstandard Device
6
6
Kinked
6
6
Expulsion
6
6
Loose or Intermittent Connection
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
1090
1090
Vomiting
1031
1031
Pain
668
669
Insufficient Information
557
557
No Clinical Signs, Symptoms or Conditions
469
469
Abdominal Pain
444
444
Nausea
442
443
Patient Problem/Medical Problem
347
347
Erosion
316
317
Dysphagia/ Odynophagia
187
188
Regurgitation
186
186
Obstruction/Occlusion
182
183
No Code Available
128
128
Unspecified Infection
128
128
No Known Impact Or Consequence To Patient
118
118
Dehydration
114
114
Pyrosis/Heartburn
111
111
Hernia
110
110
Inflammation
108
108
Weight Changes
97
97
No Information
93
93
Ulcer
73
73
No Consequences Or Impact To Patient
64
64
Malaise
63
64
Perforation
50
50
Internal Organ Perforation
49
49
Hemorrhage/Bleeding
46
46
Adhesion(s)
42
43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
39
39
Scar Tissue
38
38
Fever
38
38
Discomfort
36
36
Constipation
35
35
Complaint, Ill-Defined
32
32
Death
32
32
Diarrhea
32
32
Dyspnea
31
31
Sepsis
31
31
Aspiration/Inhalation
30
30
Abdominal Cramps
30
30
Abdominal Distention
30
30
Irritation
29
29
Chest Pain
28
28
Perforation of Esophagus
27
27
Foreign Body In Patient
26
26
Gastritis
25
25
Pneumonia
24
24
Blood Loss
24
24
Other (for use when an appropriate patient code cannot be identified)
24
24
Surgical procedure, additional
23
23
Recalls
Manufacturer
Recall Class
Date Posted
1
Allergan
II
May-02-2011
2
Allergan
II
Nov-18-2010
3
Apollo Endosurgery Inc
II
Aug-10-2018
4
Apollo Endosurgery Inc
II
Sep-30-2014
5
Ethicon Endo-Surgery Inc
II
Nov-05-2013
6
Ethicon Endo-Surgery Inc
II
Nov-02-2010
7
Obalon Therapeutics Inc
II
Apr-28-2020
8
Reshape Medical Inc
II
Nov-10-2016
9
Reshape Medical Inc
II
Aug-17-2016
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