Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
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 4424 4501
2026 289 289

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 7595 7618
Material Deformation 1642 1726
Break 1336 1337
Defective Component 942 945
Fracture 823 826
Adverse Event Without Identified Device or Use Problem 800 800
Component Incompatible 614 615
Material Frayed 586 586
Crack 467 491
Material Separation 416 416
Contamination /Decontamination Problem 405 405
Failure to Infuse 397 398
Leak/Splash 304 317
Data Problem 273 273
Material Twisted/Bent 226 228
Obstruction of Flow 225 227
Detachment of Device or Device Component 221 221
Difficult or Delayed Separation 207 207
Device Dislodged or Dislocated 202 202
Material Puncture/Hole 197 197
Difficult to Remove 152 155
Loss of or Failure to Bond 143 143
Backflow 140 140
Stretched 130 130
Material Split, Cut or Torn 127 127
Activation Problem 127 127
Physical Resistance/Sticking 118 118
Deformation Due to Compressive Stress 115 115
Difficult to Flush 92 92
Improper or Incorrect Procedure or Method 89 90
Migration 84 84
Material Protrusion/Extrusion 80 80
Device Markings/Labelling Problem 80 80
No Apparent Adverse Event 75 76
Material Rupture 75 75
Material Fragmentation 70 70
Suction Problem 69 69
Burst Container or Vessel 64 64
Difficult to Advance 61 61
Expulsion 60 60
Misassembled 55 55
Product Quality Problem 55 56
Tear, Rip or Hole in Device Packaging 49 49
Difficult to Insert 45 46
Component Missing 42 42
Expiration Date Error 42 42
Migration or Expulsion of Device 39 39
Failure to Advance 39 43
Material Integrity Problem 39 40
Corroded 36 36

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13783 13897
Insufficient Information 1035 1109
Swelling/ Edema 859 860
Foreign Body In Patient 724 724
Pain 552 558
Erythema 482 482
Extravasation 351 351
Thrombosis/Thrombus 241 241
No Consequences Or Impact To Patient 219 219
Hemorrhage/Bleeding 133 133
Unspecified Infection 131 131
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 120 121
Infiltration into Tissue 102 102
Discomfort 91 91
Device Embedded In Tissue or Plaque 80 80
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
Hematoma 29 30
Chemical Exposure 27 28
Needle Stick/Puncture 27 28
Arrhythmia 26 27
Anxiety 25 25
Purulent Discharge 24 24
Sepsis 23 23
Rash 20 20
Perforation of Vessels 19 19
Fluid Discharge 18 21
Phlebitis 18 18
Unspecified Tissue Injury 18 18
Bruise/Contusion 15 15
Laceration(s) 15 15
Itching Sensation 15 15
Cardiac Arrest 15 15
Anaphylactoid 14 14
Pleural Effusion 13 13
Nausea 13 13
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
-
-