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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, retention type, balloon
Product CodeEZL
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
APOLLON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSORS INTERNATIONAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
FLUME CATHETER COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU PRIMECARE MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HR PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PATHWAY, LLC
  SUBSTANTIALLY EQUIVALENT 1
POTRERO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
SAFE MEDICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 1
SILQ TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SILQ TECHNOLOGIES, CORP.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE FLUME CATHETER COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
URETHROTECH
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 670 670
2020 711 711
2021 701 701
2022 884 884
2023 775 775
2024 199 199

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 532 532
Fluid/Blood Leak 463 463
Deflation Problem 395 395
Material Puncture/Hole 283 283
Difficult to Remove 252 252
Decrease in Pressure 233 233
Break 181 181
Material Invagination 176 176
Material Rupture 157 157
Material Split, Cut or Torn 142 142
Leak/Splash 128 128
Partial Blockage 120 120
Adverse Event Without Identified Device or Use Problem 111 111
Erratic or Intermittent Display 103 103
Failure to Infuse 87 87
Inflation Problem 81 81
Material Fragmentation 78 78
Device Fell 68 68
Device Dislodged or Dislocated 62 62
Inaccurate Flow Rate 62 62
Component Missing 60 60
Device Contamination with Chemical or Other Material 47 47
Detachment of Device or Device Component 46 46
Device Slipped 46 46
Obstruction of Flow 45 45
Failure to Deflate 44 44
Material Deformation 41 41
Patient Device Interaction Problem 39 39
Component Misassembled 37 37
Unintended Deflation 35 35
Material Integrity Problem 34 34
Fracture 32 32
No Flow 31 31
Physical Resistance/Sticking 30 30
Incorrect Measurement 30 30
Material Twisted/Bent 27 27
Dent in Material 25 25
Difficult to Insert 24 24
Patient-Device Incompatibility 23 23
Tear, Rip or Hole in Device Packaging 23 23
Deformation Due to Compressive Stress 23 23
Material Protrusion/Extrusion 23 23
Insufficient Information 21 21
Biocompatibility 21 21
Appropriate Term/Code Not Available 19 19
Complete Blockage 19 19
Calcified 18 18
Short Fill 17 17
Device Damaged Prior to Use 15 15
No Display/Image 15 15
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Material Perforation 14 14
Difficult to Advance 14 14
Temperature Problem 13 13
Nonstandard Device 13 13
Misassembled 12 12
Inadequate Instructions for Healthcare Professional 12 12
Material Discolored 12 12
Low Readings 12 12
Gas/Air Leak 11 11
Sharp Edges 11 11
Gel Leak 11 11
Off-Label Use 11 11
Disconnection 9 9
Crack 9 9
Therapeutic or Diagnostic Output Failure 9 9
Device Contaminated During Manufacture or Shipping 9 9
Contamination /Decontamination Problem 9 9
Defective Device 9 9
Missing Information 9 9
Scratched Material 8 8
Contamination 8 8
Material Too Rigid or Stiff 8 8
Product Quality Problem 7 7
Restricted Flow rate 7 7
High Readings 7 7
Device Markings/Labelling Problem 7 7
Infusion or Flow Problem 7 7
Inability to Irrigate 6 6
Inadequacy of Device Shape and/or Size 6 6
Material Separation 6 6
Fitting Problem 6 6
Use of Device Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Wrong Label 6 6
Defective Component 5 5
Delivered as Unsterile Product 5 5
Improper Flow or Infusion 5 5
Device Sensing Problem 5 5
Failure to Advance 5 5
Device Handling Problem 5 5
Material Too Soft/Flexible 4 4
Migration 4 4
Illegible Information 4 4
Output Problem 4 4
Blocked Connection 4 4
Structural Problem 4 4
Incomplete or Missing Packaging 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Inadequate or Insufficient Training 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2066 2066
No Consequences Or Impact To Patient 898 898
No Known Impact Or Consequence To Patient 662 662
Pain 212 212
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 186 186
Insufficient Information 163 163
Urinary Tract Infection 100 100
No Patient Involvement 90 90
Discomfort 68 68
Patient Problem/Medical Problem 60 60
Foreign Body In Patient 53 53
No Information 52 52
Hemorrhage/Bleeding 51 51
Hematuria 49 49
Urinary Retention 44 44
Unspecified Infection 20 20
Blood Loss 17 17
No Code Available 16 16
Genital Bleeding 14 14
Skin Inflammation/ Irritation 13 13
Device Embedded In Tissue or Plaque 8 8
Fever 7 7
Sepsis 7 7
Injury 7 7
Skin Tears 6 6
Perforation 6 6
Tissue Breakdown 6 6
Unspecified Tissue Injury 6 6
Urinary Incontinence 6 6
Inflammation 5 5
Incontinence 5 5
Laceration(s) 4 4
Internal Organ Perforation 4 4
Local Reaction 4 4
Exposure to Body Fluids 4 4
Death 4 4
Burning Sensation 4 4
Tissue Damage 3 3
Sweating 3 3
Cellulitis 3 3
Abrasion 3 3
High Blood Pressure/ Hypertension 3 3
Skin Discoloration 3 3
Necrosis 3 3
Muscle Spasm(s) 3 3
Cancer 3 3
Unspecified Gastrointestinal Problem 2 2
Alteration In Body Temperature 2 2
Fluid Discharge 2 2
Swelling/ Edema 2 2
Unspecified Kidney or Urinary Problem 2 2
Failure of Implant 2 2
Irritation 2 2
Fistula 2 2
Fatigue 2 2
Erosion 2 2
Diaphoresis 2 2
Fungal Infection 2 2
Rash 2 2
Dizziness 2 2
Anxiety 2 2
Distress 2 2
Discharge 1 1
Viral Infection 1 1
Urinary Frequency 1 1
Pressure Sores 1 1
Vomiting 1 1
Ulceration 1 1
Septic Shock 1 1
Irritability 1 1
Toxicity 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Sleep Dysfunction 1 1
Burn, Thermal 1 1
Abdominal Cramps 1 1
Anemia 1 1
Bacterial Infection 1 1
Stroke/CVA 1 1
Edema 1 1
Abdominal Pain 1 1
Headache 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Hypersensitivity/Allergic reaction 1 1
Nausea 1 1
Skin Irritation 1 1
Tachycardia 1 1
Thrombus 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Pulmonary Dysfunction 1 1
Alteration in Body Temperature 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Localized Skin Lesion 1 1
Chemical Exposure 1 1
Dysuria 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Sep-23-2021
2 Cardinal Health 200, LLC I Feb-16-2024
3 Degania Medical Devices Pvt. Ltd. II Apr-23-2020
4 Degania Silicone, Ltd. II Jan-13-2020
5 Medline Industries Inc II May-18-2020
6 Nurse Assist, LLC I Dec-20-2023
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