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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 1949 1979

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 5657 5669
Retraction Problem 3155 3168
Break 2245 2257
Fluid/Blood Leak 1907 1917
Device Contamination with Chemical or Other Material 1151 1159
Defective Component 1149 1154
Material Separation 886 894
Material Puncture/Hole 854 859
Deformation Due to Compressive Stress 742 743
Material Twisted/Bent 707 716
Material Split, Cut or Torn 605 615
Crack 544 547
Material Deformation 490 491
Adverse Event Without Identified Device or Use Problem 471 472
Contamination 414 429
Activation Problem 401 405
Detachment of Device or Device Component 340 341
Physical Resistance/Sticking 339 353
Material Protrusion/Extrusion 329 329
Material Frayed 313 313
Unraveled Material 290 290
Defective Device 251 253
Contamination /Decontamination Problem 222 222
Material Integrity Problem 220 220
Packaging Problem 191 191
Difficult to Remove 177 177
Obstruction of Flow 175 176
Difficult or Delayed Activation 165 165
Fracture 159 160
Fail-Safe Problem 156 156
Product Quality Problem 146 146
Difficult to Insert 140 140
Device Markings/Labelling Problem 124 125
Component Missing 120 120
Difficult to Advance 119 120
Material Rupture 118 118
Material Perforation 117 120
Improper or Incorrect Procedure or Method 112 112
Loose or Intermittent Connection 109 109
Nonstandard Device 104 104
Premature Separation 95 125
Connection Problem 86 86
Complete Blockage 85 85
Separation Problem 80 80
Failure to Advance 79 79
Material Fragmentation 68 70
Difficult or Delayed Separation 67 67
Dull, Blunt 63 63
Separation Failure 63 63
Fitting Problem 62 62

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19913 20017
Insufficient Information 1942 1989
Foreign Body In Patient 1002 1003
No Consequences Or Impact To Patient 484 484
Pain 434 441
Needle Stick/Puncture 401 402
Hemorrhage/Bleeding 206 206
Extravasation 142 142
Exposure to Body Fluids 130 131
Phlebitis 114 114
Swelling/ Edema 103 103
Bacterial Infection 97 98
Perforation of Vessels 95 100
Thrombosis/Thrombus 86 86
Discomfort 85 90
Hypersensitivity/Allergic reaction 85 85
Skin Inflammation/ Irritation 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 79 79
Device Embedded In Tissue or Plaque 77 77
Hematoma 72 77
Infiltration into Tissue 60 63
Unspecified Infection 57 57
No Patient Involvement 52 52
Erythema 50 50
Bruise/Contusion 49 49
Low Blood Pressure/ Hypotension 36 36
Inflammation 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
Skin Tears 13 13
Necrosis 12 12
Sepsis 11 11
Ecchymosis 11 11
Abrasion 11 11
Hyperglycemia 10 10
Fever 10 10
Foreign Body Embolism 10 10
Chemical Exposure 10 10
Unspecified Tissue Injury 10 11
Abscess 9 9
Rash 9 10
Blood Loss 8 8
Hemolysis 8 8
Anxiety 7 7
Tachycardia 7 7
Easy Bruising 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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