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TPLC
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show TPLC since
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Device
port & catheter, implanted, subcutaneous, intravascular
Product Code
LJT
Regulation Number
880.5965
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANGIODYNAMICS, INC.
SUBSTANTIALLY EQUIVALENT
1
BARD PERIPHERAL VASCULAR, INC.
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
765
765
2020
959
959
2021
1285
1285
2022
1334
1334
2023
1225
1225
2024
1138
1138
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
2303
2303
Adverse Event Without Identified Device or Use Problem
1231
1231
Fluid/Blood Leak
1008
1008
Material Separation
884
884
Deformation Due to Compressive Stress
731
731
Migration
595
595
Suction Problem
571
571
Difficult to Flush
423
423
Naturally Worn
420
420
Obstruction of Flow
377
377
Break
302
302
Detachment of Device or Device Component
216
216
Difficult to Remove
160
160
Material Protrusion/Extrusion
159
159
Stretched
150
150
Disconnection
143
143
Component Missing
131
131
Defective Component
125
125
Material Puncture/Hole
111
111
Failure to Advance
99
99
Material Deformation
97
97
Air/Gas in Device
95
95
Migration or Expulsion of Device
93
93
Failure to Infuse
87
87
Difficult to Insert
84
84
Appropriate Term/Code Not Available
81
81
Expulsion
80
80
Material Integrity Problem
74
74
Blocked Connection
73
73
Improper or Incorrect Procedure or Method
70
70
Material Split, Cut or Torn
63
63
Dent in Material
60
60
Physical Resistance/Sticking
60
60
Leak/Splash
57
57
Tear, Rip or Hole in Device Packaging
56
56
Difficult or Delayed Separation
55
55
Material Twisted/Bent
50
50
Device Damaged Prior to Use
49
49
Device Dislodged or Dislocated
44
44
Crack
43
43
Device Appears to Trigger Rejection
43
43
Entrapment of Device
42
42
Device Tipped Over
36
36
Loose or Intermittent Connection
34
34
Infusion or Flow Problem
30
30
Material Frayed
30
30
Component Misassembled
30
30
Insufficient Information
29
29
Device Contamination with Chemical or Other Material
28
28
Device Contaminated During Manufacture or Shipping
26
26
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2974
2974
No Consequences Or Impact To Patient
708
708
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
593
593
Pain
383
383
Unspecified Infection
342
342
Insufficient Information
266
266
Swelling/ Edema
217
217
Extravasation
208
208
Arrhythmia
184
184
Injury
183
183
Foreign Body In Patient
179
179
Thrombosis/Thrombus
177
177
No Patient Involvement
150
150
Bacterial Infection
145
145
Device Embedded In Tissue or Plaque
90
90
Sepsis
90
90
No Known Impact Or Consequence To Patient
89
89
Skin Erosion
67
67
Swelling
59
59
Embolism
55
55
Embolism/Embolus
46
46
Discomfort
45
45
Pneumothorax
43
43
Chest Pain
42
42
Pulmonary Embolism
35
35
Failure of Implant
35
35
Erythema
34
34
Infiltration into Tissue
29
29
Neck Pain
28
28
Hemorrhage/Bleeding
27
27
Thrombus
25
25
Inflammation
24
24
Fever
23
23
Phlebitis
23
23
Hypersensitivity/Allergic reaction
23
23
Hematoma
22
22
Burning Sensation
20
20
Itching Sensation
19
19
Bruise/Contusion
19
19
Cellulitis
18
18
Fungal Infection
17
17
Rash
16
16
Perforation of Vessels
15
15
Implant Pain
15
15
Wound Dehiscence
14
14
Edema
12
12
Death
11
11
No Information
10
10
Septic Shock
10
10
Obstruction/Occlusion
10
10
Recalls
Manufacturer
Recall Class
Date Posted
1
Angiodynamics Inc. (Navilyst Medical Inc.)
II
Apr-21-2021
2
Angiodynamics Inc. (Navilyst Medical Inc.)
II
Nov-21-2019
3
Angiodynamics, Inc.
II
Oct-25-2022
4
Bard Peripheral Vascular Inc
II
May-10-2021
5
Bard Peripheral Vascular Inc
II
May-12-2020
6
Bard Peripheral Vascular Inc
II
Mar-26-2020
7
Bard Peripheral Vascular Inc
II
Nov-27-2019
8
Bard Peripheral Vascular Inc
II
Jul-25-2019
9
Medical Components, Inc dba MedComp
II
Mar-08-2021
10
Smiths Medical ASD Inc.
II
Jul-04-2020
11
Smiths Medical ASD Inc.
II
Oct-24-2019
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