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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cardiac catheterization 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 CodeOES
Regulation Number 870.1200
Device Class 2

MDR Year MDR Reports MDR Events
2021 21 21
2022 13 13
2023 18 18
2024 113 113
2025 117 117
2026 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 59 59
Crack 36 36
Material Integrity Problem 34 34
Break 32 32
Appropriate Term/Code Not Available 24 24
Air/Gas in Device 16 16
Loose or Intermittent Connection 13 13
Leak/Splash 13 13
Contamination /Decontamination Problem 11 11
Fluid/Blood Leak 9 9
Material Deformation 9 9
Contamination 8 8
Material Frayed 8 8
Obstruction of Flow 8 8
Material Fragmentation 7 7
No Apparent Adverse Event 6 6
Material Separation 6 6
Material Disintegration 6 6
Material Puncture/Hole 6 6
Tear, Rip or Hole in Device Packaging 5 5
Insufficient Information 5 5
Physical Resistance/Sticking 4 4
Packaging Problem 4 4
Fitting Problem 4 4
Unraveled Material 4 4
Material Split, Cut or Torn 3 3
Retraction Problem 3 3
Defective Component 3 3
Failure to Align 3 3
Component Missing 3 3
Detachment of Device or Device Component 2 2
Product Quality Problem 2 2
Delivered as Unsterile Product 2 2
Failure to Advance 2 2
Infusion or Flow Problem 2 2
Material Twisted/Bent 2 2
Improper Flow or Infusion 2 2
Material Discolored 2 2
Stretched 2 2
Difficult to Insert 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Unintended Movement 2 2
Device Markings/Labelling Problem 2 2
Incomplete or Inadequate Connection 2 2
Mechanical Problem 2 2
Device Dislodged or Dislocated 1 1
Melted 1 1
Nonstandard Device 1 1
Unexpected Therapeutic Results 1 1
Premature Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 264 264
Insufficient Information 45 45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Air Embolism 3 3
Hemorrhage/Bleeding 3 3
Low Blood Pressure/ Hypotension 3 3
Abrasion 2 2
Obstruction/Occlusion 2 2
Foreign Body In Patient 2 2
Exposure to Body Fluids 2 2
Arrhythmia 1 1
Cardiac Arrest 1 1
Intracranial Hemorrhage 1 1
Needle Stick/Puncture 1 1
Laceration(s) 1 1
Unspecified Kidney or Urinary Problem 1 1
Bradycardia 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AVID Medical, Inc. I May-01-2026
2 AVID Medical, Inc. II Nov-14-2024
3 American Contract Systems Inc. II Oct-16-2025
4 American Contract Systems, Inc. II Mar-21-2025
5 American Contract Systems, Inc. II Sep-24-2024
6 American Contract Systems, Inc. II Jan-26-2024
7 American Contract Systems, Inc. II Oct-26-2023
8 American Contract Systems, Inc. II Sep-08-2022
9 American Contract Systems, Inc. II May-06-2022
10 Cardinal Health 200, LLC II Jul-10-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
12 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
13 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
19 MEDLINE INDUSTRIES, LP - Northfield I Aug-08-2024
20 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
21 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
23 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
24 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
25 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
26 Medline Industries, LP II Jun-12-2026
27 Medline Industries, LP I May-08-2026
28 Medline Industries, LP II May-07-2026
29 Medline Industries, LP II Apr-30-2026
30 Medline Industries, LP II Apr-17-2026
31 Medline Industries, LP II Apr-17-2026
32 Medline Industries, LP I Apr-07-2026
33 Medline Industries, LP II Feb-17-2026
34 Medline Industries, LP II Feb-09-2026
35 Medline Industries, LP II Jan-28-2026
36 Medline Industries, LP II Nov-14-2025
37 ROi CPS LLC II Apr-25-2023
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