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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device occluder, catheter tip
Regulation Description Catheter tip occluder.
Product CodeDQT
Regulation Number 870.1370
Device Class 2

MDR Year MDR Reports MDR Events
2020 11 11
2021 2 2
2022 5 5
2023 4 4
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 7 7
Fracture 4 4
Activation, Positioning or Separation Problem 3 3
Protective Measures Problem 3 3
Material Fragmentation 2 2
Failure to Deflate 2 2
Material Frayed 1 1
Leak/Splash 1 1
Break 1 1
Mechanical Problem 1 1
Unsealed Device Packaging 1 1
Material Integrity Problem 1 1
Unraveled Material 1 1
Packaging Problem 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Device Embedded In Tissue or Plaque 6 6
Laceration(s) 3 3
No Consequences Or Impact To Patient 3 3
Perforation 2 2
Exposure to Body Fluids 2 2
Death 1 1
Vascular Dissection 1 1
Foreign Body In Patient 1 1
No Patient Involvement 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LeMaitre Vascular, Inc. II May-12-2025
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