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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
2019 22 22
2020 64 64
2021 54 54
2022 81 81
2023 56 56
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 108 108
Tear, Rip or Hole in Device Packaging 80 80
No Apparent Adverse Event 26 26
Material Separation 24 24
Material Frayed 15 15
Contamination /Decontamination Problem 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Appropriate Term/Code Not Available 7 7
Fluid/Blood Leak 7 7
Fracture 5 5
Material Fragmentation 5 5
Break 5 5
Degraded 4 4
Material Integrity Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Packaging Problem 3 3
Contamination 3 3
Crack 2 2
Leak/Splash 2 2
Mechanical Problem 2 2
Defective Component 2 2
Component Missing 1 1
Dull, Blunt 1 1
Malposition of Device 1 1
Unraveled Material 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Material Discolored 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
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 252 252
No Known Impact Or Consequence To Patient 12 12
No Patient Involvement 10 10
No Consequences Or Impact To Patient 9 9
Foreign Body In Patient 7 7
Air Embolism 5 5
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hemorrhage/Bleeding 2 2
Reaction 2 2
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 Cardinal Health 200, LLC II Mar-15-2021
4 DeRoyal Industries Inc II Jul-03-2023
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
9 Medline Industries Inc II Oct-07-2020
10 Merit Medical Systems, Inc. II Dec-29-2020
11 Merit Medical Systems, Inc. II Apr-13-2020
12 Merit Medical Systems, Inc. II Oct-01-2019
13 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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