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
Regulation Description Electrosurgical cutting and coagulation device and accessories.
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 5
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 63 63
2022 59 60
2023 99 99
2024 59 59
2025 48 48
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 229 230
Break 21 21
Material Deformation 20 20
Obstruction of Flow 15 15
Material Puncture/Hole 10 10
Material Separation 8 8
Use of Device Problem 8 8
Crack 7 7
Detachment of Device or Device Component 7 7
High impedance 5 5
Malposition of Device 4 4
Fluid/Blood Leak 3 3
Material Fragmentation 3 3
Positioning Problem 3 3
Separation Problem 3 3
Mechanical Problem 2 2
Fracture 2 2
Insufficient Information 2 2
Tear, Rip or Hole in Device Packaging 1 1
Positioning Failure 1 1
Connection Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 85
Arrhythmia 55 56
Cardiac Perforation 39 39
Hemorrhage/Bleeding 25 25
Stroke/CVA 20 20
Tachycardia 18 18
Hernia 11 11
Perforation 10 10
Cardiac Arrest 9 9
Great Vessel Perforation 8 8
Pericardial Effusion 7 7
Low Blood Pressure/ Hypotension 6 6
Heart Block 6 6
Bradycardia 6 6
Anemia 6 6
Atrial Fibrillation 6 6
Fistula 5 5
Foreign Body In Patient 5 5
Cardiac Tamponade 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Pulmonary Embolism 3 3
Transient Ischemic Attack 3 3
Atrial Flutter 3 3
Low Oxygen Saturation 3 3
Pleural Effusion 3 3
Mitral Valve Insufficiency/ Regurgitation 3 3
Vomiting 3 3
Lactate Dehydrogenase Increased 3 3
Perforation of Vessels 3 3
Shock 3 3
Myocardial Infarction 3 3
Pulmonary Edema 3 3
Swelling/ Edema 3 3
Muscle Weakness 2 2
Hematoma 2 2
Burn(s) 2 2
Chest Pain 2 2
Discomfort 2 2
Dyspnea 2 2
Abdominal Pain 2 2
Sepsis 2 2
Device Embedded In Tissue or Plaque 1 1
Ischemia Stroke 1 1
Dysphasia 1 1
ST Segment Elevation 1 1
Melena 1 1
Loss of consciousness 1 1
Unspecified Heart Problem 1 1
Ulcer 1 1
Convulsion/Seizure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Perfusion Systems II May-25-2022
2 Medtronic Perfusion Systems II Nov-19-2021
-
-