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 surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Definition Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Product CodeOCL
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRICURE INC.
  SUBSTANTIALLY EQUIVALENT 2
ATRICURE, INC
  SUBSTANTIALLY EQUIVALENT 3
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 49 49
2020 37 37
2021 63 63
2022 59 59
2023 99 99
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 259 259
Material Deformation 15 15
Break 13 13
Material Puncture/Hole 9 9
Material Separation 9 9
Detachment of Device or Device Component 8 8
Malposition of Device 4 4
Crack 4 4
Material Fragmentation 4 4
Use of Device Problem 4 4
Separation Problem 3 3
Insufficient Information 3 3
No Flow 3 3
High impedance 2 2
Off-Label Use 2 2
Positioning Problem 2 2
Insufficient Flow or Under Infusion 2 2
Fracture 2 2
Fluid/Blood Leak 2 2
Fire 1 1
Smoking 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Positioning Failure 1 1
Obstruction of Flow 1 1
Gas/Air Leak 1 1
Device Handling Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Appropriate Term/Code Not Available 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 54 54
Arrhythmia 45 45
Stroke/CVA 30 30
Cardiac Perforation 26 26
Hemorrhage/Bleeding 26 26
Pericardial Effusion 18 18
Tachycardia 14 14
Blood Loss 14 14
Perforation 14 14
Anemia 12 12
Hernia 11 11
Death 10 10
Cardiac Arrest 9 9
Pleural Effusion 8 8
Great Vessel Perforation 8 8
Bradycardia 7 7
Low Blood Pressure/ Hypotension 7 7
Cardiac Tamponade 7 7
No Consequences Or Impact To Patient 7 7
Atrial Fibrillation 6 6
Heart Block 6 6
Respiratory Failure 6 6
Complete Heart Block 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Fistula 5 5
Swelling/ Edema 4 4
Myocardial Infarction 4 4
No Known Impact Or Consequence To Patient 4 4
Perforation of Vessels 3 3
Extubate 3 3
Transient Ischemic Attack 3 3
Atrial Flutter 3 3
Low Oxygen Saturation 3 3
Shock 3 3
Pulmonary Edema 3 3
Lactate Dehydrogenase Increased 3 3
Pulmonary Embolism 3 3
Dyspnea 3 3
Vomiting 3 3
Mitral Valve Insufficiency/ Regurgitation 3 3
No Patient Involvement 3 3
Tissue Damage 2 2
Ulceration 2 2
Discomfort 2 2
Chest Pain 2 2
Hematoma 2 2
Vascular Dissection 2 2
Perforation of Esophagus 2 2
Sepsis 2 2
Abdominal Pain 2 2

Recalls
Manufacturer Recall Class Date Posted
1 AtriCure, Inc. II Jun-26-2019
2 AtriCure, Inc. II Feb-14-2019
3 MEDTRONIC ATS MEDICAL, INC. II Nov-25-2020
4 Medtronic Perfusion Systems II May-25-2022
5 Medtronic Perfusion Systems II Nov-19-2021
-
-