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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
SE - WITH LIMITATIONS
1
SUBSTANTIALLY EQUIVALENT
2
BRIGHTWATER MEDICAL
SUBSTANTIALLY EQUIVALENT
1
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.
SE - WITH LIMITATIONS
1
SUBSTANTIALLY EQUIVALENT
1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
M.I.TECH CO., LTD.
SE - WITH LIMITATIONS
2
MICRO-TECH (NANJING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
S&G BIOTECH INC.
SE - WITH LIMITATIONS
1
TAEWOONG MEDICAL CO., LTD
SE - WITH LIMITATIONS
2
MDR Year
MDR Reports
MDR Events
2019
1895
1895
2020
2181
2181
2021
2297
2297
2022
1749
1749
2023
1624
1624
2024
231
231
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
2192
2192
Break
892
892
Improper or Incorrect Procedure or Method
777
777
Material Puncture/Hole
760
760
Adverse Event Without Identified Device or Use Problem
689
689
Material Deformation
614
614
Burst Container or Vessel
571
571
Off-Label Use
528
528
Detachment of Device or Device Component
420
420
Difficult to Remove
389
389
Migration
347
347
Activation, Positioning or Separation Problem
341
341
Device Dislodged or Dislocated
329
329
Difficult to Advance
267
267
Use of Device Problem
258
258
Activation Failure
230
230
Leak/Splash
228
228
Positioning Failure
224
224
Fracture
208
208
Material Twisted/Bent
191
191
Dent in Material
180
180
Premature Activation
168
168
Inflation Problem
139
139
Difficult or Delayed Positioning
126
126
Failure to Advance
124
124
Entrapment of Device
114
114
Material Integrity Problem
99
99
Obstruction of Flow
95
95
Material Separation
93
93
Positioning Problem
89
89
Physical Resistance/Sticking
81
81
Deflation Problem
76
76
Migration or Expulsion of Device
70
70
Defective Device
63
63
Material Split, Cut or Torn
58
58
Mechanical Jam
58
58
Appropriate Term/Code Not Available
55
55
Deformation Due to Compressive Stress
54
54
Crack
47
47
Difficult or Delayed Activation
46
46
Stretched
45
45
Tear, Rip or Hole in Device Packaging
43
43
Device Damaged Prior to Use
41
41
Defective Component
41
41
Unsealed Device Packaging
41
41
Malposition of Device
40
40
Fluid/Blood Leak
38
38
Retraction Problem
37
37
Device-Device Incompatibility
31
31
Insufficient Information
31
31
Device Contaminated During Manufacture or Shipping
26
26
Material Protrusion/Extrusion
25
25
Therapy Delivered to Incorrect Body Area
25
25
Device Contamination with Chemical or Other Material
23
23
Failure to Deflate
22
22
Loss of or Failure to Bond
21
21
Difficult to Insert
20
20
Device Markings/Labelling Problem
20
20
Partial Blockage
18
18
Material Fragmentation
17
17
Device Damaged by Another Device
17
17
Device Stenosis
15
15
No Apparent Adverse Event
15
15
Packaging Problem
15
15
Complete Blockage
15
15
Problem with Sterilization
14
14
Unintended Movement
14
14
Structural Problem
14
14
Material Perforation
12
12
Component Missing
11
11
Material Frayed
11
11
Activation Problem
11
11
Misfire
10
10
Unraveled Material
9
9
Mechanical Problem
7
7
Difficult to Open or Remove Packaging Material
7
7
Separation Failure
6
6
Contamination
6
6
Product Quality Problem
6
6
Peeled/Delaminated
5
5
Patient-Device Incompatibility
5
5
Patient Device Interaction Problem
5
5
Device Handling Problem
4
4
Poor Visibility
4
4
Inadequacy of Device Shape and/or Size
4
4
Material Disintegration
4
4
Unintended Ejection
4
4
Calcified
3
3
Device Slipped
3
3
Nonstandard Device
3
3
Delivered as Unsterile Product
3
3
Device Difficult to Setup or Prepare
3
3
Separation Problem
3
3
Premature Separation
3
3
Noise, Audible
3
3
Therapeutic or Diagnostic Output Failure
3
3
Output Problem
3
3
Contamination /Decontamination Problem
3
3
Failure to Align
3
3
Difficult to Open or Close
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5267
5267
No Consequences Or Impact To Patient
2786
2786
No Known Impact Or Consequence To Patient
800
800
Insufficient Information
220
220
Obstruction/Occlusion
200
200
Inflammation
159
159
Perforation
149
149
Foreign Body In Patient
141
141
Hemorrhage/Bleeding
113
113
No Patient Involvement
97
97
No Code Available
81
81
Pain
72
72
Pancreatitis
72
72
Occlusion
66
66
Device Embedded In Tissue or Plaque
62
62
Thrombosis/Thrombus
53
53
Stenosis
49
49
Abdominal Pain
46
46
Vascular Dissection
44
44
Restenosis
42
42
Unspecified Infection
41
41
Patient Problem/Medical Problem
40
40
Hematoma
36
36
Sepsis
35
35
Blood Loss
33
33
Fever
32
32
Abscess
31
31
Reocclusion
30
30
Failure of Implant
28
28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
27
27
Thrombosis
25
25
Jaundice
25
25
Injury
23
23
No Information
23
23
Death
21
21
Pseudoaneurysm
20
20
Peritonitis
20
20
Bowel Perforation
16
16
Ischemia
16
16
Renal Failure
15
15
Aneurysm
14
14
Embolism
13
13
Thrombus
13
13
Vomiting
13
13
Rupture
13
13
Discomfort
13
13
Perforation of Vessels
12
12
Embolism/Embolus
11
11
Stroke/CVA
11
11
Fistula
11
11
Unspecified Tissue Injury
11
11
Unspecified Hepatic or Biliary Problem
10
10
Myocardial Infarction
10
10
Low Blood Pressure/ Hypotension
8
8
Bacterial Infection
8
8
Erosion
8
8
Nausea
7
7
Pneumonia
7
7
Gastrointestinal Hemorrhage
7
7
Swelling/ Edema
7
7
Unintended Radiation Exposure
6
6
Laceration(s)
6
6
Hyperbilirubinemia
6
6
Arrhythmia
6
6
Cardiac Arrest
5
5
Hemoptysis
5
5
Internal Organ Perforation
5
5
Urinary Tract Infection
5
5
Septic Shock
5
5
Complaint, Ill-Defined
4
4
Claudication
4
4
Pleural Effusion
4
4
Chest Pain
4
4
Aspiration/Inhalation
4
4
Bradycardia
4
4
Intimal Dissection
4
4
Fluid Discharge
4
4
Pulmonary Embolism
3
3
Pneumothorax
3
3
Rash
3
3
Necrosis
3
3
Hypersensitivity/Allergic reaction
3
3
High Blood Pressure/ Hypertension
3
3
Fatigue
3
3
Diaphoresis
3
3
Aortic Dissection
3
3
Respiratory Insufficiency
3
3
Unspecified Vascular Problem
3
3
Shock
3
3
Great Vessel Perforation
3
3
Burning Sensation
2
2
Swelling
2
2
Vasoconstriction
2
2
Tissue Damage
2
2
Ulcer
2
2
Reaction
2
2
Dizziness
2
2
Heart Failure/Congestive Heart Failure
2
2
Vascular System (Circulation), Impaired
2
2
Ascites
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
Cordis Corporation
II
Nov-12-2021
10
Cordis US Corp
II
Jul-11-2022
11
Hobbs Medical, Inc.
II
Oct-07-2022
12
Olympus Corporation of the Americas
II
Jan-31-2024
13
W.L. Gore & Associates, Inc.
II
Feb-22-2024
14
W.L. Gore & Associates, Inc.
II
May-14-2021
15
Wilson-Cook Medical Inc.
II
Dec-01-2023
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