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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
Product CodeLJS
Regulation Number 880.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS VASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
ACCESS VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOWY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC (BARD HAS JOINED BD)
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
JET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS, INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1
PICCOLO MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
PIPER ACCESS LLC
  SUBSTANTIALLY EQUIVALENT 1
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2321 2321
2019 2051 2051
2020 2539 2539
2021 3085 3085
2022 3264 3264
2023 786 786

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 4173 4173
Break 1440 1440
Material Deformation 1320 1320
Adverse Event Without Identified Device or Use Problem 778 778
Fracture 773 773
Leak/Splash 663 663
Material Frayed 513 513
Crack 506 506
Component Incompatible 495 495
Defective Component 418 418
Detachment of Device or Device Component 319 319
Material Separation 316 316
Failure to Infuse 304 304
Material Puncture/Hole 300 300
Material Twisted/Bent 240 240
Device Dislodged or Dislocated 205 205
Obstruction of Flow 187 187
Physical Resistance/Sticking 185 185
Material Split, Cut or Torn 184 184
Contamination /Decontamination Problem 164 164
Material Rupture 156 156
Data Problem 116 116
Difficult to Remove 112 112
Deformation Due to Compressive Stress 111 111
Backflow 102 102
Burst Container or Vessel 93 93
Stretched 91 91
Material Fragmentation 90 90
Failure to Advance 80 80
Appropriate Term/Code Not Available 78 78
Hole In Material 77 77
Migration or Expulsion of Device 76 76
Difficult to Insert 70 70
Malposition of Device 70 70
Device Markings/Labelling Problem 67 67
Difficult or Delayed Separation 67 67
Suction Problem 67 67
Difficult to Flush 65 65
Improper or Incorrect Procedure or Method 60 60
Migration 60 60
Difficult to Advance 60 60
Loss of or Failure to Bond 59 59
Expiration Date Error 57 57
Positioning Problem 55 55
Complete Blockage 53 53
Unraveled Material 53 53
Device Operates Differently Than Expected 52 52
Defective Device 51 51
Component Missing 51 51
Kinked 49 49
Material Integrity Problem 47 47
Entrapment of Device 46 46
Device Contamination with Chemical or Other Material 45 45
Material Protrusion/Extrusion 44 44
Detachment Of Device Component 44 44
Tear, Rip or Hole in Device Packaging 44 44
Flushing Problem 40 40
Nonstandard Device 39 39
Unable to Obtain Readings 39 39
Infusion or Flow Problem 39 39
Fitting Problem 38 38
Misassembled 37 37
Disconnection 37 37
Insufficient Information 37 37
Mushroomed 33 33
Therapeutic or Diagnostic Output Failure 32 32
No Apparent Adverse Event 31 31
Patient-Device Incompatibility 29 29
Loose or Intermittent Connection 29 29
Incorrect, Inadequate or Imprecise Result or Readings 29 29
Corroded 28 28
Device Damaged Prior to Use 26 26
Peeled/Delaminated 24 24
Physical Resistance 24 24
Connection Problem 23 23
No Flow 22 22
Material Perforation 21 21
Occlusion Within Device 20 20
Coagulation in Device or Device Ingredient 20 20
Restricted Flow rate 20 20
Improper Flow or Infusion 19 19
Split 19 19
Torn Material 19 19
Material Discolored 18 18
No Display/Image 17 17
Unsealed Device Packaging 17 17
Expulsion 17 17
Output Problem 17 17
Device Sensing Problem 15 15
Unintended Movement 15 15
Noise, Audible 15 15
Separation Problem 15 15
Product Quality Problem 14 14
Contamination 14 14
Bent 14 14
Loosening of Implant Not Related to Bone-Ingrowth 13 13
Activation, Positioning or Separation Problem 13 13
Aspiration Issue 12 12
Gas/Air Leak 12 12
Partial Blockage 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5543 5543
No Consequences Or Impact To Patient 3124 3124
No Known Impact Or Consequence To Patient 2325 2325
Foreign Body In Patient 503 503
Swelling/ Edema 479 479
Insufficient Information 447 447
Erythema 447 447
No Code Available 251 251
No Patient Involvement 232 232
Pain 224 224
No Information 196 196
Unspecified Infection 152 152
Device Embedded In Tissue or Plaque 139 139
Thrombus 116 116
Swelling 98 98
Extravasation 93 93
Thrombosis/Thrombus 84 84
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 66 66
Infiltration into Tissue 66 66
Hemorrhage/Bleeding 54 54
Thrombosis 50 50
Fever 45 45
Bacterial Infection 41 41
Discomfort 33 33
Injury 27 27
Blood Loss 27 27
Failure of Implant 25 25
Hypersensitivity/Allergic reaction 23 23
Sepsis 23 23
Reaction 22 22
Itching Sensation 21 21
Rash 21 21
Dyspnea 21 21
Death 20 20
Hematoma 20 20
Chest Pain 19 19
Edema 18 18
Phlebitis 18 18
Needle Stick/Puncture 16 16
Pleural Effusion 14 14
Inflammation 14 14
Arrhythmia 14 14
Chemical Exposure 14 14
Skin Inflammation/ Irritation 13 13
Cardiac Tamponade 12 12
Anxiety 11 11
Burning Sensation 11 11
Exposure to Body Fluids 11 11
Bruise/Contusion 11 11
Cardiac Arrest 11 11
Purulent Discharge 11 11
Laceration(s) 10 10
Perforation of Vessels 10 10
Tissue Damage 10 10
Tachycardia 8 8
Numbness 8 8
Nausea 8 8
Embolism 8 8
Embolus 8 8
Cellulitis 8 8
Premature Labor 7 7
Discharge 7 7
Patient Problem/Medical Problem 7 7
Fluid Discharge 7 7
Tingling 6 6
Urticaria 6 6
Air Embolism 6 6
Local Reaction 6 6
Irritation 5 5
Foreign Body Reaction 5 5
Fungal Infection 5 5
Chills 5 5
Pneumothorax 5 5
Thromboembolism 5 5
Unspecified Tissue Injury 5 5
Pericardial Effusion 5 5
Embolism/Embolus 4 4
Foreign Body Embolism 4 4
Respiratory Distress 4 4
Scar Tissue 4 4
Skin Erosion 4 4
Great Vessel Perforation 4 4
High Blood Pressure/ Hypertension 4 4
Perforation 4 4
Occlusion 4 4
Nerve Damage 3 3
Pneumonia 3 3
Hypoglycemia 3 3
Low Blood Pressure/ Hypotension 3 3
Vessel Or Plaque, Device Embedded In 3 3
Pulmonary Embolism 3 3
Stroke/CVA 3 3
Ventricular Tachycardia 3 3
Anaphylactoid 3 3
Septic Shock 3 3
Ulcer 3 3
Hernia 3 3
Loss of consciousness 3 3
Abdominal Distention 3 3
Cardiac Perforation 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Access Vascular, Inc II May-18-2023
2 Access Vascular, Inc. II Nov-08-2022
3 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-11-2018
4 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
5 Angiodynamics, Inc. II Jun-17-2020
6 Arrow International Inc II Feb-14-2020
7 Arrow International Inc II Jun-16-2019
8 Arrow International Inc II May-16-2019
9 Arrow International Inc II Sep-19-2018
10 Arrow International Inc II Jul-08-2018
11 Arrow International Inc II May-30-2018
12 Arrow International Inc II Apr-10-2018
13 Arrow International Inc II Mar-14-2018
14 Arrow International Inc II Feb-22-2018
15 Arrow International Inc II Feb-13-2018
16 Bard Access Systems Inc. II Jul-01-2021
17 Bard Access Systems Inc. II Jun-30-2021
18 Bard Access Systems Inc. II May-20-2021
19 Bard Access Systems Inc. II Feb-06-2018
20 Bard Peripheral Vascular Inc II Feb-01-2023
21 Becton Dickinson & Company II May-21-2020
22 Medical Components, Inc dba MedComp II Oct-25-2019
23 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
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