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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
2021 2 2
2022 5 5
2023 4 4
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 3 3
Protective Measures Problem 3 3
Failure to Deflate 2 2
Material Frayed 1 1
Unsealed Device Packaging 1 1
Material Integrity Problem 1 1
Packaging Problem 1 1
Retraction 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 5 5
Laceration(s) 3 3
Exposure to Body Fluids 2 2
Device Embedded In Tissue or Plaque 2 2
Foreign Body In Patient 1 1
Insufficient Information 1 1

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