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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, intravascular, therapeutic, long-term greater than 30 days
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Product CodeLJS
Regulation Number 880.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 4
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
L&Z US, INC.
  SUBSTANTIALLY EQUIVALENT 3
NAVI MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
PICCOLO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
SPECTRUM VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3084 3102
2022 3256 3278
2023 2799 2824
2024 4243 4248
2025 4424 4501
2026 1123 1123

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 7982 8005
Material Deformation 1745 1829
Break 1400 1401
Defective Component 942 945
Fracture 870 873
Adverse Event Without Identified Device or Use Problem 829 829
Component Incompatible 626 627
Material Frayed 606 606
Crack 476 500
Material Separation 435 435
Contamination /Decontamination Problem 429 429
Failure to Infuse 408 409
Leak/Splash 322 335
Data Problem 285 285
Detachment of Device or Device Component 242 242
Material Twisted/Bent 236 238
Obstruction of Flow 232 234
Difficult or Delayed Separation 221 221
Device Dislodged or Dislocated 219 219
Material Puncture/Hole 218 218
Difficult to Remove 159 162
Backflow 152 152
Loss of or Failure to Bond 150 150
Stretched 142 142
Material Split, Cut or Torn 136 136
Activation Problem 132 132
Physical Resistance/Sticking 124 124
Deformation Due to Compressive Stress 122 122
Difficult to Flush 98 98
Improper or Incorrect Procedure or Method 97 98
Migration 90 90
Product Quality Problem 89 90
Material Protrusion/Extrusion 88 88
Device Markings/Labelling Problem 88 88
No Apparent Adverse Event 77 78
Burst Container or Vessel 77 77
Material Rupture 76 76
Suction Problem 71 71
Material Fragmentation 71 71
Difficult to Advance 62 62
Expulsion 62 62
Misassembled 57 57
Tear, Rip or Hole in Device Packaging 52 52
Difficult to Insert 50 51
Failure to Advance 45 49
Component Missing 43 43
Expiration Date Error 42 42
Material Integrity Problem 42 43
Migration or Expulsion of Device 39 39
Unable to Obtain Readings 36 36

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14427 14541
Insufficient Information 1086 1160
Swelling/ Edema 887 888
Foreign Body In Patient 751 751
Pain 573 579
Erythema 489 489
Extravasation 370 370
Thrombosis/Thrombus 256 256
No Consequences Or Impact To Patient 219 219
Unspecified Infection 143 143
Hemorrhage/Bleeding 138 138
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 128 129
Infiltration into Tissue 104 104
Discomfort 103 103
Device Embedded In Tissue or Plaque 83 83
Bacterial Infection 60 60
Skin Inflammation/ Irritation 59 59
Failure of Implant 54 57
Fever 46 46
Burning Sensation 45 45
Hypersensitivity/Allergic reaction 44 44
Inflammation 40 40
Dyspnea 36 36
Distress 32 32
Needle Stick/Puncture 30 31
Hematoma 30 31
Purulent Discharge 29 29
Chemical Exposure 27 28
Arrhythmia 26 27
Anxiety 25 25
Sepsis 24 24
Unspecified Tissue Injury 21 21
Phlebitis 21 21
Rash 20 20
Fluid Discharge 20 23
Perforation of Vessels 19 19
Bruise/Contusion 16 16
Anaphylactoid 16 16
Itching Sensation 15 15
Laceration(s) 15 15
Cardiac Arrest 15 15
Pleural Effusion 13 13
Nausea 13 13
Exposure to Body Fluids 13 13
Low Blood Pressure/ Hypotension 12 12
Chest Pain 12 12
Fungal Infection 11 11
Air Embolism 11 11
Local Reaction 10 10
Embolism/Embolus 9 9

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 Argon Medical Devices, Inc II Aug-16-2024
7 Bard Access Systems Inc. II Jul-01-2021
8 Bard Access Systems Inc. II Jun-30-2021
9 Bard Access Systems Inc. II May-20-2021
10 Bard Access Systems, Inc. I Apr-16-2025
11 Bard Peripheral Vascular Inc II Feb-13-2026
12 Bard Peripheral Vascular Inc II Feb-01-2023
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