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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device device, angioplasty, laser, coronary
Product CodeLPC
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
1 2 4 4 2 0

MDR Year MDR Reports MDR Events
2020 7 7
2021 7 129
2022 15 15
2023 23 23
2024 12 12
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 20 20
Power Problem 12 12
Detachment of Device or Device Component 8 8
Material Separation 8 8
Sharp Edges 4 4
Break 4 4
Failure to Calibrate 3 3
Material Integrity Problem 2 2
Material Frayed 1 1
Failure to Deliver Energy 1 123
Material Puncture/Hole 1 1
Material Deformation 1 1
Device Displays Incorrect Message 1 1
Material Twisted/Bent 1 1
Calibration Problem 1 1
Energy Output Problem 1 1
Failure to Recalibrate 1 1
Failure to Align 1 1
Material Split, Cut or Torn 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 152
Perforation of Vessels 18 18
Thrombosis/Thrombus 14 14
Unintended Radiation Exposure 8 8
Iatrogenic Source 4 4
Radiation Exposure, Unintended 3 3
Insufficient Information 2 2
Cardiac Perforation 2 2
No Known Impact Or Consequence To Patient 2 2
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Spectranetics Corporation II Nov-11-2022
2 Spectranetics Corporation II Jul-11-2022
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