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 microspheres radionuclide
Definition Approved PMA: P990065
Product CodeNAW
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 3 2 3 5 1

MDR Year MDR Reports MDR Events
2020 28 28
2021 76 76
2022 23 23
2023 37 37
2024 53 53
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 214 214
Insufficient Information 4 4
Radiation Underexposure 2 2
Detachment of Device or Device Component 2 2
Device Contamination with Chemical or Other Material 2 2
Leak/Splash 1 1
Device Contaminated During Manufacture or Shipping 1 1
Malposition of Device 1 1
Physical Resistance/Sticking 1 1
Therapeutic or Diagnostic Output Failure 1 1
Air/Gas in Device 1 1
Backflow 1 1
Use of Device Problem 1 1
Infusion or Flow Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Migration 1 1
Inaccurate Delivery 1 1
Connection Problem 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ascites 47 47
Abdominal Pain 45 45
Inflammation 36 36
Unintended Radiation Exposure 35 35
Liver Damage/Dysfunction 31 31
Nausea 28 28
Dyspnea 26 26
Fatigue 23 23
Fever 21 21
Pain 21 21
No Clinical Signs, Symptoms or Conditions 20 20
Hyperbilirubinemia 17 17
Hemorrhage/Bleeding 16 16
Vomiting 12 12
Decreased Appetite 11 11
Encephalopathy 10 10
Ulcer 10 10
Abscess 9 9
Low White Blood Cell Count 9 9
Muscle Weakness 8 8
Swelling/ Edema 8 8
Necrosis 8 8
Constipation 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Liver Failure 8 8
Unspecified Infection 8 8
Jaundice 7 7
Pleural Effusion 7 7
Insufficient Information 6 6
Chills 6 6
Death 5 5
Cough 5 5
Weight Changes 5 5
Confusion/ Disorientation 5 5
Thrombosis/Thrombus 5 5
Bacterial Infection 4 4
Thrombocytopenia 4 4
Sepsis 4 4
Renal Failure 4 4
Pneumonia 4 4
Stenosis 3 3
Radiation Sickness Syndrome 3 3
Fistula 3 3
Flatus 3 3
Diarrhea 3 3
Obstruction/Occlusion 3 3
Anemia 3 3
Test Result 3 3
Chest Pain 2 2
High Blood Pressure/ Hypertension 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Aug-19-2021
-
-