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TPLC
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Device
catheter, urological
Product Code
KOD
Regulation Number
876.5130
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALLWIN MEDICAL DEVICES, INC
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
2
CONVATEC LIMITED
SUBSTANTIALLY EQUIVALENT
2
CONVATEC LTD.
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
4
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
PLUROMED, INC.
SUBSTANTIALLY EQUIVALENT
3
ROBLING MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
UROGEN PHARMA LTD
SUBSTANTIALLY EQUIVALENT
1
UROGEN PHARMA LTD.
SUBSTANTIALLY EQUIVALENT
1
WELL LEAD MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
225
225
2015
417
417
2016
284
284
2017
1873
1873
2018
1180
1180
2019
1167
1167
2020
1370
1370
2021
1387
1387
2022
1280
1280
2023
1162
1162
2024
514
514
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
1044
1044
Difficult to Insert
718
718
Product Quality Problem
697
697
Adverse Event Without Identified Device or Use Problem
583
583
Component Missing
552
552
Difficult to Remove
545
545
Material Twisted/Bent
544
544
Deflation Problem
533
533
Material Integrity Problem
474
474
Improper Chemical Reaction
401
401
Device Operates Differently Than Expected
391
391
Nonstandard Device
369
369
Incorrect Measurement
344
344
Short Fill
334
334
Fluid/Blood Leak
295
295
Break
255
255
Component Misassembled
254
254
Decrease in Pressure
253
253
Device Damaged Prior to Use
232
232
Misassembled
212
212
Patient-Device Incompatibility
187
187
Leak/Splash
181
181
Material Puncture/Hole
175
175
Partial Blockage
172
172
Material Rupture
170
170
Material Deformation
160
160
Sharp Edges
143
143
Device Misassembled During Manufacturing /Shipping
135
135
Failure to Infuse
130
130
Inadequacy of Device Shape and/or Size
125
125
Biocompatibility
122
122
Bent
118
118
Contamination /Decontamination Problem
111
111
Defective Device
109
109
Material Fragmentation
107
107
Scratched Material
106
106
Inaccurate Flow Rate
105
105
Insufficient Information
100
100
Material Too Rigid or Stiff
96
96
No Flow
94
94
Defective Component
92
92
Inflation Problem
91
91
Material Split, Cut or Torn
91
91
Device Contamination with Chemical or Other Material
91
91
Packaging Problem
85
85
Unsealed Device Packaging
78
78
Tear, Rip or Hole in Device Packaging
77
77
Material Protrusion/Extrusion
72
72
Difficult to Open or Remove Packaging Material
70
70
Failure to Align
70
70
Manufacturing, Packaging or Shipping Problem
64
64
Patient Device Interaction Problem
64
64
Device Handling Problem
60
60
Failure to Advance
58
58
Inability to Irrigate
58
58
Device Slipped
57
57
Moisture or Humidity Problem
50
50
Device Packaging Compromised
50
50
Appropriate Term/Code Not Available
48
48
Use of Device Problem
48
48
Device Fell
47
47
Obstruction of Flow
46
46
Detachment of Device or Device Component
46
46
Deformation Due to Compressive Stress
44
44
Improper or Incorrect Procedure or Method
43
43
Material Separation
42
42
Therapeutic or Diagnostic Output Failure
38
38
Physical Resistance/Sticking
33
33
Device Dislodged or Dislocated
33
33
Hole In Material
33
33
Device Contaminated During Manufacture or Shipping
30
30
Device Markings/Labelling Problem
29
29
Positioning Problem
29
29
Unintended Deflation
29
29
Failure to Deflate
28
28
Difficult to Advance
27
27
Fracture
27
27
Sticking
27
27
Incomplete or Missing Packaging
27
27
Structural Problem
25
25
Naturally Worn
24
24
Out-Of-Box Failure
23
23
Device Inoperable
22
22
Malposition of Device
22
22
Inadequate Instructions for Healthcare Professional
21
21
Filling Problem
21
21
Disconnection
21
21
Illegible Information
21
21
Infusion or Flow Problem
20
20
Restricted Flow rate
20
20
Mechanical Problem
20
20
Peeled/Delaminated
20
20
Contamination
19
19
Crack
19
19
Material Too Soft/Flexible
19
19
Physical Property Issue
18
18
Degraded
18
18
Delivered as Unsterile Product
18
18
Detachment Of Device Component
17
17
Cut In Material
17
17
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3401
3401
No Known Impact Or Consequence To Patient
3012
3013
No Consequences Or Impact To Patient
2246
2246
Urinary Tract Infection
799
800
Pain
685
685
No Patient Involvement
667
667
Hemorrhage/Bleeding
445
445
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
398
398
No Information
386
387
Patient Problem/Medical Problem
356
356
Discomfort
339
340
Blood Loss
141
141
Hematuria
126
126
No Code Available
116
116
Unspecified Infection
105
105
Urinary Retention
95
95
Foreign Body In Patient
82
82
Irritation
73
73
Bacterial Infection
60
60
Insufficient Information
59
59
Injury
39
39
Tissue Damage
35
35
Burning Sensation
31
31
Sepsis
26
26
Abdominal Pain
25
25
Abrasion
25
25
Device Embedded In Tissue or Plaque
24
24
Abdominal Distention
24
24
Laceration(s)
22
22
Skin Inflammation/ Irritation
22
22
Tissue Breakdown
21
21
Fever
20
20
Perforation
18
18
Swelling
16
16
Skin Irritation
14
14
Inadequate Pain Relief
13
13
Bruise/Contusion
13
13
Incontinence
12
12
Inflammation
11
11
Death
11
11
Alteration In Body Temperature
11
11
Irritability
11
11
Obstruction/Occlusion
11
11
Swelling/ Edema
11
11
Exposure to Body Fluids
10
10
Fistula
10
10
Hypersensitivity/Allergic reaction
10
10
High Blood Pressure/ Hypertension
9
9
Internal Organ Perforation
9
9
Renal Failure
9
9
Dysuria
9
9
Complaint, Ill-Defined
9
9
Anxiety
9
9
Chills
8
8
Urinary Frequency
7
7
Cancer
7
7
Skin Tears
7
7
Septic Shock
7
7
Skin Discoloration
7
7
Low Blood Pressure/ Hypotension
7
7
Itching Sensation
7
7
Hematoma
7
7
Unspecified Tissue Injury
7
7
Urinary Incontinence
6
6
Cramp(s) /Muscle Spasm(s)
6
6
Unspecified Gastrointestinal Problem
6
6
Muscle Spasm(s)
6
6
Rash
6
6
Nausea
5
5
Erosion
4
4
Abscess
4
4
Distress
4
4
Fungal Infection
4
4
Genital Bleeding
4
4
Reaction
3
3
Pseudoaneurysm
3
3
Test Result
3
3
Anemia
3
3
Chest Pain
3
3
Erythema
3
3
Hyperglycemia
3
3
Micturition Urgency
3
3
Headache
3
3
Diarrhea
3
3
Dyspnea
3
3
Pneumonia
3
3
Pneumothorax
2
2
Local Reaction
2
2
Increased Sensitivity
2
2
Scar Tissue
2
2
Myocardial Infarction
2
2
Emotional Changes
2
2
Cardiac Arrest
2
2
Confusion/ Disorientation
2
2
Abdominal Cramps
2
2
Respiratory Failure
2
2
Post Operative Wound Infection
2
2
Extubate
2
2
Impaired Healing
2
2
Pressure Sores
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Apr-11-2012
2
Boston Scientific Corporation
II
Jan-21-2010
3
C.R. Bard Inc
II
Feb-24-2022
4
C.R. Bard, Inc.
II
Apr-16-2021
5
C.R. Bard, Inc.
II
Sep-03-2015
6
C.R. Bard, Inc.
II
Aug-14-2015
7
C.R. Bard, Inc., Urological Division
II
Oct-04-2012
8
COVIDIEN LLC
II
Sep-20-2018
9
Cardinal Health 200, LLC
I
Feb-16-2024
10
ConvaTec, Inc
II
Mar-21-2019
11
Convatec Inc.
II
Mar-20-2014
12
Covidien Llc
II
May-14-2020
13
Nurse Assist, Inc
II
Jan-11-2012
14
Nurse Assist, Inc
II
May-25-2011
15
Rochester Medical Corp
II
Mar-16-2009
16
TELEFLEX LLC
II
Nov-11-2022
17
Teleflex Medical
II
Jul-26-2019
18
Teleflex Medical
II
Dec-16-2016
19
Teleflex Medical
II
Sep-18-2014
20
Teleflex Medical
II
Jun-09-2014
21
Teleflex Medical
II
Aug-03-2011
22
Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN
II
Jan-25-2011
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