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TPLC
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Device
port & catheter, implanted, subcutaneous, intravascular
Regulation Description
Subcutaneous, implanted, intravascular infusion port and catheter.
Product Code
LJT
Regulation Number
880.5965
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANGIODYNAMICS, INC.
SUBSTANTIALLY EQUIVALENT
1
BARD ACCESS SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
BARD PERIPHERAL VASCULAR, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
959
959
2021
1285
1285
2022
1334
1334
2023
1225
1225
2024
1897
1897
2025
216
216
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
2506
2506
Adverse Event Without Identified Device or Use Problem
1564
1564
Fluid/Blood Leak
993
993
Material Separation
982
982
Deformation Due to Compressive Stress
841
841
Migration
681
681
Suction Problem
579
579
Difficult to Flush
475
475
Naturally Worn
466
466
Obstruction of Flow
402
402
Detachment of Device or Device Component
197
197
Difficult to Remove
184
184
Stretched
168
168
Material Protrusion/Extrusion
167
167
Disconnection
151
151
Material Puncture/Hole
119
119
Break
118
118
Failure to Advance
113
113
Expulsion
105
105
Air/Gas in Device
102
102
Difficult to Insert
100
100
Material Deformation
86
86
Material Integrity Problem
83
83
Blocked Connection
78
78
Migration or Expulsion of Device
77
77
Component Missing
77
77
Device Damaged Prior to Use
76
76
Physical Resistance/Sticking
72
72
Material Split, Cut or Torn
71
71
Improper or Incorrect Procedure or Method
70
70
Defective Component
68
68
Difficult or Delayed Separation
61
61
Dent in Material
60
60
Failure to Infuse
58
58
Material Twisted/Bent
55
55
Leak/Splash
52
52
Tear, Rip or Hole in Device Packaging
52
52
Device Appears to Trigger Rejection
49
49
Entrapment of Device
41
41
Device Tipped Over
39
39
Loose or Intermittent Connection
39
39
Insufficient Information
39
39
Unraveled Material
35
35
Crack
35
35
Device Contaminated During Manufacture or Shipping
34
34
Component Misassembled
33
33
Loss of or Failure to Bond
31
31
Device Dislodged or Dislocated
31
31
Infusion or Flow Problem
30
30
Packaging Problem
30
30
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3358
3358
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
673
673
Unspecified Infection
550
550
Pain
403
403
No Consequences Or Impact To Patient
365
365
Thrombosis/Thrombus
318
318
Insufficient Information
275
275
Swelling/ Edema
270
270
Extravasation
206
206
Arrhythmia
185
185
Foreign Body In Patient
175
175
Bacterial Infection
173
173
Sepsis
98
98
Skin Erosion
87
87
Injury
84
84
No Patient Involvement
66
66
Device Embedded In Tissue or Plaque
62
62
Embolism/Embolus
49
49
Discomfort
49
49
Chest Pain
46
46
Pneumothorax
43
43
Pulmonary Embolism
38
38
Failure of Implant
36
36
No Known Impact Or Consequence To Patient
36
36
Hemorrhage/Bleeding
35
35
Fever
34
34
Erythema
32
32
Swelling
29
29
Infiltration into Tissue
28
28
Hypersensitivity/Allergic reaction
27
27
Neck Pain
25
25
Inflammation
24
24
Phlebitis
23
23
Hematoma
21
21
Cellulitis
21
21
Bruise/Contusion
20
20
Burning Sensation
19
19
Thrombus
19
19
Implant Pain
18
18
Itching Sensation
17
17
Fungal Infection
17
17
Rash
16
16
Skin Inflammation/ Irritation
14
14
Wound Dehiscence
14
14
Septic Shock
13
13
Tachycardia
13
13
Obstruction/Occlusion
12
12
Perforation of Vessels
12
12
Dyspnea
12
12
Air Embolism
10
10
Recalls
Manufacturer
Recall Class
Date Posted
1
Angiodynamics Inc. (Navilyst Medical Inc.)
II
Apr-21-2021
2
Angiodynamics, Inc.
II
Oct-25-2022
3
Bard Peripheral Vascular Inc
II
May-10-2021
4
Bard Peripheral Vascular Inc
II
May-12-2020
5
Bard Peripheral Vascular Inc
II
Mar-26-2020
6
Medical Components, Inc dba MedComp
II
Mar-08-2021
7
Smiths Medical ASD Inc.
II
Jul-04-2020
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