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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
2016 44 44
2017 42 42
2018 58 58
2019 71 71
2020 65 65
2021 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Tear, Rip or Hole in Device Packaging 39 39
Fluid Leak 28 28
Disconnection 26 26
Air Leak 25 25
Problem with Sterilization 18 18
Material Fragmentation 17 17
Leak/Splash 17 17
Device Contamination with Chemical or Other Material 15 15
Break 12 12
Contamination /Decontamination Problem 10 10
Connection Problem 8 8
Material Frayed 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Device Reprocessing Problem 7 7
Crack 7 7
Unsealed Device Packaging 7 7
Material Separation 6 6
Material Puncture/Hole 4 4
Fracture 4 4
Component Missing 4 4
Improper Flow or Infusion 4 4
Insufficient Information 4 4
Device Handling Problem 4 4
Material Rupture 4 4
Device Contaminated During Manufacture or Shipping 3 3
No Flow 3 3
Packaging Problem 3 3
Detachment of Device or Device Component 3 3
Fire 3 3
Particulates 2 2
Degraded 2 2
Hole In Material 2 2
Device Operational Issue 2 2
Device Dislodged or Dislocated 2 2
Defective Device 2 2
Uncoiled 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Contamination 2 2
Misconnection 2 2
Incomplete or Inadequate Connection 2 2
Air/Gas in Device 2 2
Component Misassembled 1 1
Device Fell 1 1
Increase in Pressure 1 1
Loose or Intermittent Connection 1 1
Material Discolored 1 1
Facilities Issue 1 1
Defective Component 1 1
Use of Device Problem 1 1
Metal Shedding Debris 1 1
Suction Problem 1 1
Microbial Contamination of Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Infusion or Flow Problem 1 1
Inflation Problem 1 1
Nonstandard Device 1 1
Material Disintegration 1 1
Difficult to Remove 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 88 88
Blood Loss 63 63
No Clinical Signs, Symptoms or Conditions 43 43
No Patient Involvement 40 40
No Consequences Or Impact To Patient 34 34
Not Applicable 30 30
Death 7 7
Air Embolism 7 7
Insufficient Information 6 6
Foreign Body In Patient 5 5
No Information 5 5
Post Operative Wound Infection 3 3
Hemolysis 3 3
Patient Problem/Medical Problem 2 2
Cardiac Arrest 2 2
Stroke/CVA 2 2
Arrhythmia 1 1
Exposure to Body Fluids 1 1
Device Embedded In Tissue or Plaque 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Seizures 1 1
Therapeutic Response, Decreased 1 1
Ventilator Dependent 1 1
Sudden Cardiac Death 1 1
Burn(s) 1 1
Hepatitis 1 1
Ischemia 1 1
ST Segment Elevation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AngioDynamics Inc. II Apr-07-2016
2 Avid Medical, Inc. I Jun-04-2021
3 Avid Medical, Inc. II Mar-19-2020
4 Medline Industries Inc II Jan-07-2021
5 ROi CPS LLC II Apr-08-2021
6 Terumo Cardiovascular Systems Corp II Jul-26-2018
7 Terumo Cardiovascular Systems Corp II Apr-06-2018
8 Terumo Cardiovascular Systems Corp II Aug-31-2016
9 Terumo Cardiovascular Systems Corporation II Feb-27-2019
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