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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device angiography/angioplasty kit
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 CodeOEQ
Regulation Number 870.1650
Device Class 2

MDR Year MDR Reports MDR Events
2018 14 14
2019 22 22
2020 64 64
2021 54 54
2022 81 81
2023 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 96 96
Tear, Rip or Hole in Device Packaging 74 74
No Apparent Adverse Event 25 25
Material Separation 24 24
Material Frayed 15 15
Contamination /Decontamination Problem 10 10
Device Contamination with Chemical or Other Material 8 8
Fluid/Blood Leak 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Fracture 5 5
Material Fragmentation 5 5
Degraded 4 4
Packaging Problem 4 4
Leak/Splash 3 3
Material Integrity Problem 3 3
Material Protrusion/Extrusion 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 2 2
Mechanical Problem 2 2
Break 2 2
Defective Component 2 2
Particulates 2 2
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Component Missing 1 1
Unraveled Material 1 1
Contamination 1 1
Crack 1 1
Material Discolored 1 1
Appropriate Term/Code Not Available 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Air/Gas in Device 1 1
Gas/Air Leak 1 1
Device Contaminated During Manufacture or Shipping 1 1
Detachment of Device or Device Component 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Dull, Blunt 1 1
Defective Device 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 211 211
No Known Impact Or Consequence To Patient 21 21
No Consequences Or Impact To Patient 12 12
No Patient Involvement 11 11
Foreign Body In Patient 7 7
Air Embolism 5 5
Hemorrhage/Bleeding 2 2
Reaction 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Information 1 1
Perforation 1 1
Perforation of Vessels 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Sep-08-2022
3 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-17-2018
4 Cardinal Health 200, LLC II Mar-15-2021
5 DeRoyal Industries Inc II Jul-03-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
10 Medline Industries Inc II Oct-07-2020
11 Merit Medical Systems, Inc. II Dec-29-2020
12 Merit Medical Systems, Inc. II Apr-13-2020
13 Merit Medical Systems, Inc. II Oct-01-2019
14 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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