Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
catheter, intravascular, therapeutic, long-term greater than 30 days
Product Code
LJS
Regulation Number
880.5970
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACCESS VASCULAR INC
SUBSTANTIALLY EQUIVALENT
1
1. K213550
HydroPICC 5F Dual Lumen Catheter
ACCESS VASCULAR, INC
SUBSTANTIALLY EQUIVALENT
1
ARGON MEDICAL DEVICES
SUBSTANTIALLY EQUIVALENT
1
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
SUBSTANTIALLY EQUIVALENT
1
BARD ACCESS SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
BIOWY CORPORATION
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
L&Z US, INC.
SUBSTANTIALLY EQUIVALENT
3
PICCOLO MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
2051
2051
2020
2539
2539
2021
3084
3084
2022
3256
3256
2023
2802
2802
2024
790
790
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
4645
4645
Material Deformation
1478
1478
Break
1296
1296
Fracture
810
810
Defective Component
803
803
Adverse Event Without Identified Device or Use Problem
787
787
Component Incompatible
570
570
Material Frayed
563
563
Crack
491
491
Leak/Splash
425
425
Failure to Infuse
392
392
Material Separation
339
339
Detachment of Device or Device Component
300
300
Material Puncture/Hole
282
282
Material Twisted/Bent
239
239
Contamination /Decontamination Problem
214
214
Device Dislodged or Dislocated
198
198
Obstruction of Flow
189
189
Material Split, Cut or Torn
177
177
Data Problem
174
174
Physical Resistance/Sticking
172
172
Deformation Due to Compressive Stress
144
144
Material Rupture
132
132
Difficult to Remove
112
112
Backflow
107
107
Stretched
102
102
Difficult or Delayed Separation
101
101
Difficult to Flush
78
78
Loss of or Failure to Bond
76
76
Material Fragmentation
72
72
Device Markings/Labelling Problem
67
67
Failure to Advance
64
64
Burst Container or Vessel
64
64
Improper or Incorrect Procedure or Method
62
62
Suction Problem
62
62
Migration
60
60
Difficult to Insert
59
59
Expiration Date Error
54
54
Difficult to Advance
53
53
Migration or Expulsion of Device
51
51
Misassembled
49
49
Tear, Rip or Hole in Device Packaging
48
48
Material Protrusion/Extrusion
47
47
Component Missing
44
44
Malposition of Device
43
43
Unable to Obtain Readings
41
41
Complete Blockage
41
41
No Apparent Adverse Event
41
41
Entrapment of Device
38
38
Defective Device
38
38
Corroded
37
37
Unraveled Material
36
36
Fitting Problem
33
33
Therapeutic or Diagnostic Output Failure
32
32
Infusion or Flow Problem
31
31
Material Integrity Problem
30
30
Positioning Problem
30
30
Appropriate Term/Code Not Available
30
30
Device Contamination with Chemical or Other Material
29
29
Flushing Problem
28
28
Incorrect, Inadequate or Imprecise Result or Readings
28
28
Expulsion
25
25
Insufficient Information
25
25
Coagulation in Device or Device Ingredient
24
24
Disconnection
23
23
Peeled/Delaminated
22
22
Loose or Intermittent Connection
22
22
Restricted Flow rate
20
20
Separation Problem
20
20
Device Damaged Prior to Use
19
19
Material Discolored
18
18
Unsealed Device Packaging
17
17
Patient-Device Incompatibility
17
17
Output Problem
17
17
Improper Flow or Infusion
16
16
Material Perforation
15
15
Misconnection
15
15
Nonstandard Device
14
14
No Display/Image
14
14
Activation Problem
14
14
Air/Gas in Device
14
14
Loosening of Implant Not Related to Bone-Ingrowth
13
13
Connection Problem
13
13
Contamination
12
12
Noise, Audible
12
12
Unintended Movement
11
11
Gas/Air Leak
11
11
Unexpected Shutdown
11
11
Material Erosion
11
11
Product Quality Problem
11
11
Separation Failure
11
11
Device Sensing Problem
10
10
Illegible Information
10
10
No Flow
10
10
Component Misassembled
9
9
Activation, Positioning or Separation Problem
9
9
Reflux within Device
9
9
Device Slipped
9
9
Difficult or Delayed Positioning
9
9
Degraded
8
8
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7779
7779
No Consequences Or Impact To Patient
2697
2697
No Known Impact Or Consequence To Patient
1047
1047
Insufficient Information
652
652
Swelling/ Edema
557
557
Foreign Body In Patient
545
545
Erythema
460
460
Pain
245
245
No Patient Involvement
163
163
Unspecified Infection
150
150
No Code Available
121
121
Extravasation
110
110
Device Embedded In Tissue or Plaque
107
107
Thrombosis/Thrombus
106
106
Thrombus
87
87
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
81
81
No Information
76
76
Infiltration into Tissue
71
71
Hemorrhage/Bleeding
68
68
Swelling
64
64
Fever
45
45
Discomfort
41
41
Failure of Implant
40
40
Bacterial Infection
37
37
Thrombosis
27
27
Skin Inflammation/ Irritation
27
27
Hypersensitivity/Allergic reaction
26
26
Purulent Discharge
23
23
Injury
23
23
Chemical Exposure
21
21
Dyspnea
21
21
Phlebitis
20
20
Rash
19
19
Hematoma
19
19
Sepsis
19
19
Blood Loss
17
17
Needle Stick/Puncture
17
17
Itching Sensation
17
17
Death
16
16
Reaction
16
16
Arrhythmia
15
15
Bruise/Contusion
14
14
Cardiac Arrest
14
14
Perforation of Vessels
13
13
Exposure to Body Fluids
12
12
Edema
12
12
Inflammation
12
12
Unspecified Tissue Injury
12
12
Pleural Effusion
11
11
Cellulitis
11
11
Chest Pain
11
11
Laceration(s)
10
10
Cardiac Tamponade
10
10
Anxiety
9
9
Nausea
9
9
Fluid Discharge
8
8
Embolism/Embolus
8
8
Air Embolism
7
7
Discharge
7
7
Premature Labor
7
7
Fungal Infection
6
6
Burning Sensation
6
6
Tachycardia
6
6
Stroke/CVA
6
6
Embolism
5
5
Foreign Body Reaction
5
5
Local Reaction
5
5
Tissue Damage
5
5
Numbness
5
5
Urticaria
5
5
Convulsion/Seizure
5
5
Foreign Body Embolism
4
4
Patient Problem/Medical Problem
4
4
Pneumothorax
4
4
Scar Tissue
4
4
Great Vessel Perforation
4
4
Tingling
4
4
Chills
4
4
Irritation
4
4
High Blood Pressure/ Hypertension
4
4
Hypoglycemia
4
4
Low Blood Pressure/ Hypotension
4
4
Nerve Damage
3
3
Occlusion
3
3
Emotional Changes
3
3
Pulmonary Embolism
3
3
Ulcer
3
3
Septic Shock
3
3
Perforation
3
3
Skin Erosion
3
3
Cardiac Perforation
3
3
Pallor
3
3
Obstruction/Occlusion
2
2
Loss of consciousness
2
2
Sedation
2
2
Confusion/ Disorientation
2
2
Lethargy
2
2
Thromboembolism
2
2
Skin Irritation
2
2
Distress
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
ARROW INTERNATIONAL Inc.
I
Oct-05-2023
2
ARROW INTERNATIONAL Inc.
II
Sep-15-2023
3
Access Vascular, Inc
II
Oct-13-2023
4
Access Vascular, Inc
II
May-18-2023
5
Access Vascular, Inc.
II
Nov-08-2022
6
Angiodynamics, Inc.
II
Jun-17-2020
7
Arrow International Inc
II
Feb-14-2020
8
Arrow International Inc
II
Jun-16-2019
9
Arrow International Inc
II
May-16-2019
10
Bard Access Systems Inc.
II
Jul-01-2021
11
Bard Access Systems Inc.
II
Jun-30-2021
12
Bard Access Systems Inc.
II
May-20-2021
13
Bard Peripheral Vascular Inc
II
Feb-01-2023
14
Becton Dickinson & Company
II
May-21-2020
15
Medical Components, Inc dba MedComp
II
Oct-25-2019
-
-