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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 1
ACCESS VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 1
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
NAVI MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PICCOLO MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
PICCOLO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2539 2539
2021 3084 3084
2022 3256 3256
2023 2804 2804
2024 4246 4246
2025 1689 1766

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 6872 6872
Material Deformation 1695 1772
Break 1374 1374
Defective Component 930 930
Fracture 849 849
Adverse Event Without Identified Device or Use Problem 808 808
Material Frayed 631 631
Component Incompatible 618 618
Crack 505 505
Material Separation 421 421
Failure to Infuse 418 418
Contamination /Decontamination Problem 347 347
Leak/Splash 300 300
Detachment of Device or Device Component 255 255
Data Problem 230 230
Material Twisted/Bent 227 227
Material Puncture/Hole 219 219
Device Dislodged or Dislocated 215 215
Obstruction of Flow 203 203
Difficult or Delayed Separation 168 168
Material Split, Cut or Torn 159 159
Physical Resistance/Sticking 139 139
Difficult to Remove 137 137
Deformation Due to Compressive Stress 137 137
Stretched 129 129
Loss of or Failure to Bond 128 128
Backflow 124 124
Material Rupture 96 96
Activation Problem 96 96
Difficult to Flush 89 89
Improper or Incorrect Procedure or Method 82 82
Material Fragmentation 75 75
Device Markings/Labelling Problem 73 73
Burst Container or Vessel 67 67
Suction Problem 67 67
Migration 67 67
Material Protrusion/Extrusion 66 66
No Apparent Adverse Event 62 62
Difficult to Insert 57 57
Difficult to Advance 53 53
Migration or Expulsion of Device 51 51
Tear, Rip or Hole in Device Packaging 50 50
Expulsion 50 50
Misassembled 49 49
Failure to Advance 49 49
Expiration Date Error 45 45
Component Missing 43 43
Unable to Obtain Readings 43 43
Material Integrity Problem 40 40
Corroded 38 38

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11753 11830
No Consequences Or Impact To Patient 1892 1892
Insufficient Information 866 914
Swelling/ Edema 776 776
Foreign Body In Patient 692 692
Erythema 474 474
Pain 471 471
Extravasation 275 275
Thrombosis/Thrombus 194 194
No Known Impact Or Consequence To Patient 194 194
Unspecified Infection 149 149
No Patient Involvement 120 120
Hemorrhage/Bleeding 100 100
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 97 97
Device Embedded In Tissue or Plaque 87 87
Infiltration into Tissue 78 78
Discomfort 71 71
Thrombus 65 65
No Code Available 57 57
Failure of Implant 51 51
Fever 49 49
Skin Inflammation/ Irritation 48 48
Bacterial Infection 40 40
Hypersensitivity/Allergic reaction 35 35
Burning Sensation 34 34
Swelling 34 34
Inflammation 33 33
Dyspnea 31 31
Needle Stick/Puncture 27 27
Chemical Exposure 25 25
No Information 23 23
Sepsis 23 23
Arrhythmia 23 23
Hematoma 22 22
Distress 22 22
Phlebitis 21 21
Itching Sensation 21 21
Purulent Discharge 21 21
Rash 20 20
Anxiety 20 20
Unspecified Tissue Injury 16 16
Perforation of Vessels 16 16
Bruise/Contusion 16 16
Pleural Effusion 15 15
Cardiac Arrest 14 14
Anaphylactoid 13 13
Nausea 12 12
Laceration(s) 12 12
Chest Pain 11 11
Exposure to Body Fluids 11 11

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 Argon Medical Devices, Inc II Aug-16-2024
8 Arrow International Inc II Feb-14-2020
9 Bard Access Systems Inc. II Jul-01-2021
10 Bard Access Systems Inc. II Jun-30-2021
11 Bard Access Systems Inc. II May-20-2021
12 Bard Access Systems, Inc. I Apr-16-2025
13 Bard Peripheral Vascular Inc II Feb-01-2023
14 Becton Dickinson & Company II May-21-2020
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