Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, balloon type
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGBA
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2021 20 20
2022 27 27
2023 22 22
2024 16 16
2025 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 43 43
Material Rupture 15 15
Display or Visual Feedback Problem 14 14
Leak/Splash 13 13
Adverse Event Without Identified Device or Use Problem 11 11
Material Puncture/Hole 5 5
No Visual Prompts/Feedback 3 3
Improper Flow or Infusion 3 3
Fracture 3 3
Component Missing 2 2
Inflation Problem 2 2
Deflation Problem 1 1
Device Difficult to Setup or Prepare 1 1
Misassembled 1 1
Failure to Unfold or Unwrap 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 95 95
Stroke/CVA 3 3
Hemorrhage/Bleeding 3 3
Ischemia Stroke 3 3
Vascular Dissection 2 2
Vasoconstriction 2 2
Embolism/Embolus 2 2
Obstruction/Occlusion 2 2
Hemorrhagic Stroke 2 2
Transient Ischemic Attack 2 2
Hiccups 1 1
Dizziness 1 1
Hematoma 1 1
Inflammation 1 1
Perforation 1 1
Rupture 1 1
Intracranial Hemorrhage 1 1
Paralysis 1 1
Foreign Body In Patient 1 1
Vomiting 1 1
Discomfort 1 1
Insufficient Information 1 1
Choking 1 1
Perforation of Vessels 1 1
Feeding Problem 1 1
Loss of consciousness 1 1
Fistula 1 1

-
-