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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 1
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 4427 4504

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 7467 7490
Material Deformation 1605 1689
Break 1310 1311
Defective Component 942 945
Fracture 810 813
Adverse Event Without Identified Device or Use Problem 797 797
Component Incompatible 611 612
Material Frayed 582 582
Crack 457 481
Material Separation 413 413
Failure to Infuse 392 393
Contamination /Decontamination Problem 389 389
Leak/Splash 299 312
Data Problem 269 269
Material Twisted/Bent 225 227
Obstruction of Flow 221 223
Detachment of Device or Device Component 219 219
Device Dislodged or Dislocated 203 203
Difficult or Delayed Separation 202 202
Material Puncture/Hole 191 191
Difficult to Remove 146 149
Loss of or Failure to Bond 144 144
Backflow 132 132
Stretched 129 129
Activation Problem 126 126
Material Split, Cut or Torn 125 125
Physical Resistance/Sticking 116 116
Deformation Due to Compressive Stress 114 114
Difficult to Flush 91 91
Improper or Incorrect Procedure or Method 88 89
Migration 80 80
Material Protrusion/Extrusion 79 79
Device Markings/Labelling Problem 78 78
No Apparent Adverse Event 74 75
Material Rupture 74 74
Material Fragmentation 67 67
Suction Problem 66 66
Burst Container or Vessel 62 62
Difficult to Advance 60 60
Expulsion 60 60
Misassembled 54 54
Tear, Rip or Hole in Device Packaging 48 48
Difficult to Insert 45 46
Product Quality Problem 42 43
Component Missing 42 42
Expiration Date Error 42 42
Material Integrity Problem 39 40
Migration or Expulsion of Device 38 38
Failure to Advance 38 42
Corroded 36 36

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13560 13674
Insufficient Information 1019 1093
Swelling/ Edema 851 852
Foreign Body In Patient 715 715
Pain 542 548
Erythema 482 482
Extravasation 343 343
Thrombosis/Thrombus 234 234
No Consequences Or Impact To Patient 219 219
Hemorrhage/Bleeding 131 131
Unspecified Infection 128 128
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 111 112
Infiltration into Tissue 100 100
Discomfort 89 89
Device Embedded In Tissue or Plaque 77 77
Bacterial Infection 59 59
Skin Inflammation/ Irritation 57 57
Failure of Implant 53 56
Burning Sensation 44 44
Fever 43 43
Hypersensitivity/Allergic reaction 42 42
Inflammation 38 38
Dyspnea 34 34
Distress 32 32
Chemical Exposure 27 28
Needle Stick/Puncture 27 28
Hematoma 27 28
Arrhythmia 26 27
Anxiety 25 25
Purulent Discharge 24 24
Sepsis 23 23
Rash 20 20
Phlebitis 18 18
Perforation of Vessels 18 18
Unspecified Tissue Injury 18 18
Fluid Discharge 17 20
Bruise/Contusion 15 15
Itching Sensation 15 15
Cardiac Arrest 15 15
Anaphylactoid 14 14
Pleural Effusion 13 13
Nausea 13 13
Laceration(s) 12 12
Chest Pain 12 12
Low Blood Pressure/ Hypotension 12 12
Exposure to Body Fluids 11 11
Air Embolism 10 10
Fungal Infection 9 9
Embolism/Embolus 9 9
Stroke/CVA 8 8

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-01-2023
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