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TPLC
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Device
stents, drains and dilators for the biliary ducts
Product Code
FGE
Regulation Number
876.5010
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOTEQUE CORPORATION
SUBSTANTIALLY EQUIVALENT
2
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
2
BRIGHTWATER MEDICAL
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
COOK IRELAND
SUBSTANTIALLY EQUIVALENT
1
COOK IRELAND LTD
SE - WITH LIMITATIONS
1
SUBSTANTIALLY EQUIVALENT
2
COOK IRELAND LTD.
SUBSTANTIALLY EQUIVALENT
1
DONGGUAN TT MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ENDO GI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ENDOGI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ENDOGI MEDICAL, LTD.
SUBSTANTIALLY EQUIVALENT
1
GYRUS ACMI, INC.
SUBSTANTIALLY EQUIVALENT
1
M.I.TECH CO., LTD.
SE - WITH LIMITATIONS
2
MICRO-TECH (NANJING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
TAEWOONG MEDICAL CO., LTD
SE - WITH LIMITATIONS
2
MDR Year
MDR Reports
MDR Events
2018
1680
1680
2019
1895
1895
2020
2182
2182
2021
2302
2302
2022
1755
1755
2023
637
637
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
2288
2288
Break
982
982
Material Puncture/Hole
788
788
Adverse Event Without Identified Device or Use Problem
679
679
Improper or Incorrect Procedure or Method
672
672
Material Deformation
647
647
Burst Container or Vessel
585
585
Off-Label Use
487
487
Detachment of Device or Device Component
433
433
Difficult to Remove
386
386
Activation, Positioning or Separation Problem
380
380
Device Dislodged or Dislocated
341
341
Migration
302
302
Difficult to Advance
251
251
Fracture
250
250
Use of Device Problem
240
240
Positioning Failure
223
223
Leak/Splash
217
217
Activation Failure
204
204
Premature Activation
180
180
Material Twisted/Bent
172
172
Dent in Material
151
151
Inflation Problem
139
139
Migration or Expulsion of Device
128
128
Difficult or Delayed Positioning
127
127
Failure to Advance
125
125
Entrapment of Device
118
118
Obstruction of Flow
109
109
Material Integrity Problem
103
103
Positioning Problem
102
102
Deflation Problem
88
88
Material Separation
84
84
Physical Resistance/Sticking
64
64
Defective Device
59
59
Appropriate Term/Code Not Available
56
56
Crack
54
54
Kinked
52
52
Defective Component
49
49
Unintended Movement
48
48
Mechanical Jam
48
48
Malposition of Device
46
46
Device Damaged Prior to Use
45
45
Material Split, Cut or Torn
44
44
Difficult or Delayed Activation
43
43
Deformation Due to Compressive Stress
43
43
Tear, Rip or Hole in Device Packaging
42
42
Insufficient Information
40
40
Device Contamination with Chemical or Other Material
39
39
Stretched
37
37
Unsealed Device Packaging
36
36
Retraction Problem
34
34
Therapy Delivered to Incorrect Body Area
31
31
Device-Device Incompatibility
30
30
Partial Blockage
28
28
Detachment Of Device Component
27
27
Occlusion Within Device
26
26
Material Protrusion/Extrusion
25
25
Fluid/Blood Leak
24
24
Material Fragmentation
22
22
Device Contaminated During Manufacture or Shipping
20
20
Bent
19
19
Loss of or Failure to Bond
18
18
Delivery System Failure
17
17
Device Markings/Labelling Problem
17
17
Device Damaged by Another Device
16
16
Structural Problem
16
16
Packaging Problem
16
16
Calcified
16
16
Difficult to Insert
16
16
Complete Blockage
15
15
Problem with Sterilization
15
15
Material Perforation
15
15
Contamination /Decontamination Problem
15
15
No Apparent Adverse Event
14
14
Failure to Deflate
13
13
Component Missing
12
12
Material Frayed
12
12
Misfire
11
11
Activation Problem
10
10
Mechanical Problem
9
9
Unraveled Material
8
8
Hole In Material
8
8
Device Packaging Compromised
8
8
Device Stenosis
8
8
Separation Failure
7
7
Inaccurate Delivery
7
7
Difficult to Open or Remove Packaging Material
7
7
Contamination
7
7
Product Quality Problem
6
6
Difficult To Position
6
6
Human-Device Interface Problem
5
5
Device Operates Differently Than Expected
5
5
Patient-Device Incompatibility
5
5
Patient Device Interaction Problem
5
5
Separation Problem
5
5
Device Handling Problem
4
4
Device Difficult to Setup or Prepare
4
4
Material Disintegration
4
4
Unintended Ejection
4
4
Component Falling
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4202
4202
No Consequences Or Impact To Patient
3931
3931
No Known Impact Or Consequence To Patient
1011
1011
Insufficient Information
187
187
Inflammation
168
168
No Patient Involvement
164
164
Obstruction/Occlusion
164
164
Perforation
148
148
Foreign Body In Patient
141
141
Hemorrhage/Bleeding
117
117
No Code Available
104
104
Device Embedded In Tissue or Plaque
82
82
Occlusion
81
81
Patient Problem/Medical Problem
73
73
Pain
67
67
Stenosis
61
61
Pancreatitis
54
54
Thrombosis/Thrombus
53
53
Reocclusion
52
52
Abdominal Pain
48
48
Death
47
47
Vascular Dissection
46
46
Thrombosis
45
45
Restenosis
42
42
Unspecified Infection
41
41
Hematoma
38
38
Blood Loss
35
35
Fever
33
33
Failure of Implant
33
33
No Information
29
29
Sepsis
27
27
Jaundice
26
26
Injury
26
26
Abscess
25
25
Pseudoaneurysm
23
23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
23
23
Aneurysm
20
20
Peritonitis
19
19
Embolism
18
18
Ischemia
16
16
Thrombus
15
15
Bowel Perforation
15
15
Renal Failure
13
13
Rupture
13
13
Stroke/CVA
12
12
Perforation of Vessels
11
11
Embolism/Embolus
11
11
Unspecified Tissue Injury
10
10
Myocardial Infarction
10
10
Fistula
10
10
Bacterial Infection
9
9
Discomfort
9
9
Vomiting
8
8
Erosion
8
8
Low Blood Pressure/ Hypotension
8
8
Unspecified Hepatic or Biliary Problem
8
8
Swelling/ Edema
7
7
Vascular System (Circulation), Impaired
7
7
Claudication
6
6
Nausea
6
6
Laceration(s)
6
6
Arrhythmia
6
6
Intimal Dissection
5
5
Cardiac Arrest
5
5
Internal Organ Perforation
5
5
Pneumonia
5
5
Hypoxia
5
5
Septic Shock
5
5
Complaint, Ill-Defined
5
5
Cramp(s)
5
5
Gastrointestinal Hemorrhage
5
5
Unintended Radiation Exposure
4
4
Fluid Discharge
4
4
Hypersensitivity/Allergic reaction
4
4
Hemoptysis
4
4
Pleural Effusion
4
4
Necrosis
4
4
Chest Pain
4
4
Aspiration/Inhalation
4
4
Bradycardia
4
4
Vessel Or Plaque, Device Embedded In
3
3
Cellulitis
3
3
Purulent Discharge
3
3
Pneumothorax
3
3
High Blood Pressure/ Hypertension
3
3
Hyperbilirubinemia
3
3
Aortic Dissection
3
3
Thromboembolism
3
3
Reaction
3
3
Heart Failure
3
3
Vasoconstriction
3
3
Great Vessel Perforation
3
3
Rash
3
3
Shock
3
3
Tissue Damage
3
3
Respiratory Insufficiency
3
3
Unspecified Vascular Problem
3
3
Renal Impairment
2
2
Transient Ischemic Attack
2
2
Urinary Tract Infection
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Aomori Olympus Co., Ltd.
II
Feb-05-2021
2
Boston Scientific Corporation
II
Dec-01-2021
3
Boston Scientific Corporation
II
Oct-23-2020
4
Boston Scientific Corporation
II
Sep-12-2020
5
Boston Scientific Corporation
II
Nov-25-2019
6
Boston Scientific Corporation
II
Jul-09-2019
7
Boston Scientific Corporation
II
Mar-14-2019
8
Cook Inc.
II
Feb-28-2019
9
Cook Medical Incorporated
II
Oct-31-2018
10
Cordis Corporation
II
Nov-12-2021
11
Cordis Corporation
II
Jan-09-2018
12
Cordis US Corp
II
Jul-11-2022
13
Hobbs Medical, Inc.
II
Oct-07-2022
14
W.L. Gore & Associates, Inc.
II
May-14-2021
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