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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cardiovascular procedure kit
Regulation Description Diagnostic intravascular catheter.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOEZ
Regulation Number 870.1200
Device Class 2

MDR Year MDR Reports MDR Events
2021 42 42
2022 36 37
2023 24 24
2024 147 147
2025 123 123
2026 81 81

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 108 108
Loose or Intermittent Connection 34 34
Fluid/Blood Leak 26 26
Appropriate Device Problem Term/Code Not Available 25 25
Leak/Splash 22 22
Break 22 22
Adverse Event Without Identified Device or Use Problem 15 15
Material Integrity Problem 15 15
Crack 15 15
Material Separation 12 12
Material Frayed 10 10
Air/Gas in Device 9 9
Insufficient Device Problem Information 9 9
Contamination 8 8
Unsealed Device Packaging 7 7
Device Misassembled During Manufacturing /Shipping 6 6
Material Disintegration 6 6
Disconnection 6 6
Infusion or Flow Problem 5 5
Detachment of Device or Device Component 5 5
Product Quality Problem 5 5
Component Misassembled 4 4
Device Handling Problem 4 4
Pressure Problem 4 4
Incomplete or Inadequate Connection 3 3
Component Missing 3 3
Inaccurate Delivery 3 3
Gas/Air Leak 3 3
Mechanical Problem 3 3
Unintended Movement 2 2
Material Twisted/Bent 2 2
Human-Device Interface Problem 2 2
Loss of or Failure to Bond 2 2
Material Puncture/Hole 2 2
Use of Device Problem 2 2
Premature Separation 2 2
Partial Blockage 1 1
Problem with Sterilization 1 1
Material Rupture 1 1
Electrical /Electronic Property Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Fracture 1 1
Material Fragmentation 1 1
Failure to Transmit Record 1 1
Inflation Problem 1 1
Blocked Connection 1 1
Deformation Due to Compressive Stress 1 1
Premature Activation 1 1
Delivered as Unsterile Product 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 352 352
Insufficient Information 48 49
Air Embolism 18 18
Foreign Body In Patient 14 14
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 5 5
Exposure to Body Fluids 4 4
Hemolysis 3 3
No Known Impact Or Consequence To Patient 3 3
Low Blood Pressure/ Hypotension 3 3
Laceration(s) 3 3
Memory Loss/Impairment 2 2
Thrombosis/Thrombus 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Muscle Weakness/Atrophy 2 2
Cardiac Arrest 1 1
Visual Impairment 1 1
Speech Disorder 1 1
Ischemia Stroke 1 1
Perforation 1 1
Burn(s) 1 1
Skin Inflammation/ Irritation 1 1
Chemical Exposure 1 1
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL, LLC I Jun-13-2026
2 AVID Medical, Inc. I May-01-2026
3 AVID Medical, Inc. II Aug-04-2025
4 AVID Medical, Inc. II May-09-2025
5 AVID Medical, Inc. II Nov-14-2024
6 American Contract Systems Inc II Aug-28-2025
7 American Contract Systems Inc II Mar-14-2025
8 American Contract Systems Inc. II Oct-16-2025
9 American Contract Systems, Inc. II Sep-24-2024
10 American Contract Systems, Inc. II Jan-26-2024
11 American Contract Systems, Inc. II Oct-26-2023
12 American Contract Systems, Inc. II Sep-08-2022
13 Argon Medical Devices, Inc I Jul-10-2026
14 Avid Medical, Inc. I Jun-04-2021
15 Cardinal Health 200, LLC II Feb-10-2025
16 Cardinal Health 200, LLC II Jan-15-2025
17 Cardinal Health 200, LLC II Jul-10-2024
18 Cardinal Health 200, LLC II Oct-10-2023
19 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
20 MEDLINE INDUSTRIES, LP - Northfield I Apr-04-2025
21 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
22 MEDLINE INDUSTRIES, LP - Northfield II Mar-21-2025
23 MEDLINE INDUSTRIES, LP - Northfield I Jan-15-2025
24 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
25 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
26 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
27 MEDLINE INDUSTRIES, LP - Northfield II Nov-25-2024
28 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
29 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
30 MEDLINE INDUSTRIES, LP - Northfield II Oct-17-2024
31 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
32 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
33 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
34 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
35 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
36 MEDLINE INDUSTRIES, LP - Northfield II May-10-2024
37 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
38 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
39 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
40 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
41 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
42 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
43 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
44 Medline Industries Inc II Dec-10-2021
45 Medline Industries Inc II Jan-07-2021
46 Medline Industries, LP II Jul-08-2026
47 Medline Industries, LP II Jun-29-2026
48 Medline Industries, LP II Jun-26-2026
49 Medline Industries, LP II Jun-25-2026
50 Medline Industries, LP I Jun-24-2026
51 Medline Industries, LP II Jun-17-2026
52 Medline Industries, LP II Jun-12-2026
53 Medline Industries, LP I May-08-2026
54 Medline Industries, LP II May-07-2026
55 Medline Industries, LP II Apr-30-2026
56 Medline Industries, LP II Apr-17-2026
57 Medline Industries, LP II Apr-17-2026
58 Medline Industries, LP I Apr-07-2026
59 Medline Industries, LP II Apr-01-2026
60 Medline Industries, LP II Mar-12-2026
61 Medline Industries, LP II Feb-17-2026
62 Medline Industries, LP II Feb-09-2026
63 Medline Industries, LP II Jan-28-2026
64 Medline Industries, LP II Jan-14-2026
65 Medline Industries, LP II Jan-12-2026
66 Medline Industries, LP II Dec-05-2025
67 Medline Industries, LP II Nov-14-2025
68 Medline Industries, LP I Nov-13-2025
69 Medline Industries, LP I Oct-01-2025
70 Merit Medical Systems, Inc. II Jan-16-2026
71 Merit Medical Systems, Inc. II Aug-12-2025
72 Merit Medical Systems, Inc. II Aug-12-2024
73 ROi CPS LLC II Nov-16-2023
74 ROi CPS LLC II Nov-23-2022
75 ROi CPS LLC II Jul-19-2022
76 ROi CPS LLC II Jun-28-2022
77 ROi CPS LLC II May-09-2022
78 ROi CPS LLC II Apr-08-2021
79 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
80 Terumo Cardiovascular Systems Corp II Apr-18-2022
81 Terumo Cardiovascular Systems Corporation II Mar-29-2024
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