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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, short-term less than 30 days
Regulation Description Intravascular catheter.
Product CodeFOZ
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 2
B.BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
BARD ACCESS SYSTEMS, INC. (C.R. BARD, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 9
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY (BARD ACCESS SYSTEMS, INC.)
  SUBSTANTIALLY EQUIVALENT 1
COOK ADVANCED TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MEDIPLUS (INDIA) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDSOURCE INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
POLY MEDICURE LIMITED
  SUBSTANTIALLY EQUIVALENT 5
SAUDI MAIS CO. FOR MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SKYDANCE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPECTRUM VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VENOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1
WOO YOUNG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4674 4707
2022 4133 4150
2023 4430 4475
2024 4773 4808
2025 5188 5188
2026 2341 2343

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 5636 5648
Retraction Problem 3057 3058
Break 2123 2131
Fluid/Blood Leak 1819 1826
Device Contamination with Chemical or Other Material 1132 1140
Defective Component 1131 1136
Material Separation 867 876
Material Puncture/Hole 818 823
Deformation Due to Compressive Stress 743 744
Material Twisted/Bent 632 633
Material Split, Cut or Torn 567 573
Crack 490 493
Material Deformation 467 468
Adverse Event Without Identified Device or Use Problem 460 461
Contamination 420 423
Activation Problem 409 410
Material Protrusion/Extrusion 321 321
Material Frayed 310 310
Unraveled Material 284 284
Detachment of Device or Device Component 278 279
Physical Resistance/Sticking 250 260
Material Integrity Problem 228 228
Contamination /Decontamination Problem 220 220
Defective Device 209 209
Packaging Problem 189 189
Obstruction of Flow 169 170
Difficult or Delayed Activation 160 160
Fracture 155 156
Fail-Safe Problem 147 147
Difficult to Remove 147 147
Product Quality Problem 125 125
Difficult to Insert 123 123
Device Markings/Labelling Problem 123 124
Material Perforation 117 120
Nonstandard Device 115 115
Improper or Incorrect Procedure or Method 112 112
Loose or Intermittent Connection 105 105
Premature Separation 105 105
Difficult to Advance 99 99
Material Rupture 97 97
Component Missing 95 95
Complete Blockage 87 87
Separation Problem 80 80
Connection Problem 75 75
Difficult or Delayed Separation 67 67
Fitting Problem 63 63
Material Fragmentation 60 63
Air/Gas in Device 59 59
Separation Failure 57 57
Disconnection 56 56

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20215 20291
Insufficient Information 1965 2012
Foreign Body In Patient 1023 1024
No Consequences Or Impact To Patient 484 484
Pain 438 445
Needle Stick/Puncture 405 406
Hemorrhage/Blood Loss/Bleeding 212 212
Extravasation 142 142
Exposure to Body Fluids 130 131
Vasculitis 127 127
Swelling/ Edema 105 105
Perforation of Vessels 104 109
Bacterial Infection 97 98
Thrombosis/Thrombus 89 89
Discomfort 87 92
Hypersensitivity/Allergic reaction 85 85
Skin Inflammation/ Irritation 82 82
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 79 79
Device Embedded In Tissue or Plaque 78 78
Hematoma 78 83
Infiltration into Tissue 61 64
Unspecified Infection 59 59
No Patient Involvement 52 52
Erythema 50 50
Bruise/Contusion 49 49
Inflammation 36 36
Low Blood Pressure/ Hypotension 36 36
Anaphylactic Shock 26 27
Failure of Implant 22 22
Fluid Discharge 22 22
Laceration(s) 17 17
Air Embolism 17 17
Rupture 16 16
Hyperglycemia 14 14
Skin Tears 13 13
Necrosis 12 12
Unspecified Tissue Injury 11 12
Ecchymosis 11 11
Sepsis 11 11
Abrasion 11 11
Fever 10 10
Foreign Body Embolism 10 10
Chemical Exposure 10 10
Abscess 9 9
Rash 9 10
Hemolysis 8 8
Blood Loss 8 8
Tachycardia 7 7
Easy Bruising 7 7
Embolism/Embolus 7 7

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. I Oct-05-2023
2 ARROW INTERNATIONAL Inc. I Jun-21-2023
3 ARROW INTERNATIONAL Inc. I Dec-10-2022
4 ARROW INTERNATIONAL Inc. II Jun-27-2022
5 ARROW INTERNATIONAL, LLC II Apr-22-2026
6 Access Vascular, Inc II Feb-22-2023
7 Access Vascular, Inc II Feb-22-2023
8 Access Vascular, Inc II Feb-10-2023
9 Arrow International Inc II Feb-10-2021
10 B Braun Medical Inc II Mar-19-2025
11 B Braun Medical Inc II Oct-06-2022
12 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2023
13 Becton Dickinson Infusion Therapy Systems Inc. II Oct-03-2023
14 Becton Dickinson Infusion Therapy Systems Inc. II Nov-03-2022
15 Becton Dickinson Infusion Therapy Systems Inc. II Nov-24-2021
16 Becton Dickinson Infusion Therapy Systems, Inc. II Jun-23-2025
17 Becton Dickinson Infusion Therapy Systems, Inc. II May-21-2025
18 Becton Dickinson Infusion Therapy Systems, Inc. II Jul-31-2024
19 Braxton Medical Corporation II Jan-27-2021
20 Cook Incorporated II Apr-06-2026
21 Delta Med SpA II Aug-16-2021
22 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
23 Medline Industries, LP II May-07-2026
24 Medline Industries, LP II Feb-17-2026
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