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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 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 102 102
Fluid/Blood Leak 26 26
Break 25 25
Appropriate Term/Code Not Available 25 25
Loose or Intermittent Connection 21 21
Leak/Splash 20 20
Crack 17 18
Adverse Event Without Identified Device or Use Problem 17 17
Material Integrity Problem 16 16
Material Separation 11 11
Material Frayed 10 10
Insufficient Information 8 8
Contamination 8 8
Air/Gas in Device 8 8
Disconnection 7 7
Unsealed Device Packaging 7 7
Component Missing 7 7
Pressure Problem 5 5
Detachment of Device or Device Component 5 5
Infusion or Flow Problem 5 5
Device Misassembled During Manufacturing /Shipping 5 5
Component Misassembled 4 4
Material Puncture/Hole 4 4
Device Handling Problem 4 4
Delivered as Unsterile Product 4 4
Inaccurate Delivery 3 3
Tear, Rip or Hole in Device Packaging 3 3
Packaging Problem 3 3
Gas/Air Leak 3 3
Use of Device Problem 3 3
Incomplete or Inadequate Connection 3 3
Mechanical Problem 3 3
Material Fragmentation 2 2
Problem with Sterilization 2 2
Inflation Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Defective Device 2 2
Product Quality Problem 2 2
Unintended Movement 2 2
Device Contamination with Chemical or Other Material 2 2
Human-Device Interface Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Improper or Incorrect Procedure or Method 2 2
Loss of or Failure to Bond 2 2
Unraveled Material 1 1
Patient Device Interaction Problem 1 1
Obstruction of Flow 1 1
Dent in Material 1 1
Difficult or Delayed Activation 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 296 296
Insufficient Information 47 48
Air Embolism 18 18
Foreign Body In Patient 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Hemolysis 3 3
No Known Impact Or Consequence To Patient 3 3
Exposure to Body Fluids 3 3
Laceration(s) 3 3
Memory Loss/Impairment 2 2
Muscle Weakness 2 2
Hemorrhage/Bleeding 2 2
Low Blood Pressure/ Hypotension 1 1
Speech Disorder 1 1
Ischemia Stroke 1 1
Thrombosis/Thrombus 1 1
Skin Inflammation/ Irritation 1 1
Perforation 1 1
Visual Impairment 1 1
Needle Stick/Puncture 1 1
Chemical Exposure 1 1
Burn(s) 1 1
Cardiac Arrest 1 1

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