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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, ultrasound, intravascular
Regulation Description Diagnostic intravascular catheter.
Definition For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Product CodeOBJ
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CONAVI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU TINGSN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LUMA VISION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NUVERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS IMAGE GUIDED THERAPY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PROVISIO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
VOLCANO CORPORATION (DBA PHILIPS IMAGE GUIDED THERAPY DEVICE
  SUBSTANTIALLY EQUIVALENT 1
YORLABS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 353 1573
2022 473 473
2023 697 704
2024 1154 1165
2025 797 797
2026 657 657

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 949 1207
Poor Quality Image 740 746
Entrapment of Device 683 1056
Detachment of Device or Device Component 534 535
Air/Gas in Device 360 360
Material Deformation 344 345
Material Twisted/Bent 334 340
Fracture 309 309
Material Integrity Problem 288 289
No Display/Image 262 384
Difficult to Flush 207 207
Nonstandard Device 201 201
Failure to Advance 184 185
Physical Resistance/Sticking 152 153
Patient Device Interaction Problem 118 118
Material Separation 108 718
Unable to Obtain Readings 104 104
Contamination /Decontamination Problem 84 84
Connection Problem 59 59
Deformation Due to Compressive Stress 43 43
Contamination 36 36
Leak/Splash 32 32
Device Displays Incorrect Message 28 28
Difficult to Advance 26 26
Retraction Problem 25 25
Material Perforation 25 25
Device-Device Incompatibility 24 24
Display or Visual Feedback Problem 23 23
Mechanical Jam 20 20
Incorrect, Inadequate or Imprecise Result or Readings 19 19
Communication or Transmission Problem 18 18
Break 18 18
Device Contamination with Chemical or Other Material 17 17
Tear, Rip or Hole in Device Packaging 14 14
Positioning Problem 14 14
Difficult to Remove 13 13
Material Puncture/Hole 12 12
Image Display Error/Artifact 10 10
Packaging Problem 10 10
Sharp Edges 10 10
Activation, Positioning or Separation Problem 9 9
Mechanical Problem 9 9
Appropriate Device Problem Term/Code Not Available 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Noise, Audible 9 9
Difficult to Insert 8 8
Complete Loss of Power 8 8
Delivered as Unsterile Product 7 7
Component Missing 7 7
Use of Device Problem 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3630 4378
Insufficient Information 82 82
Cardiac Tamponade 81 81
Foreign Body In Patient 72 73
Air Embolism 52 53
Non specific EKG/ECG Changes 52 52
Cardiac Perforation 43 165
Cardiac Arrest 28 28
Vascular Dissection 25 147
Reduced Blood Flow 25 25
Thrombosis/Thrombus 20 20
Obstruction/Occlusion 20 20
Chest Pain 20 20
Perforation of Vessels 15 259
Low Blood Pressure/ Hypotension 13 13
Pericardial Effusion 13 13
Myocardial Infarction 12 12
Bradycardia 11 11
Arrhythmia 11 11
Perforation 9 9
No Consequences Or Impact To Patient 9 9
Ventricular Fibrillation 9 9
Heart Block 8 8
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 8 8
Hemorrhage/Blood Loss/Bleeding 8 8
Tachycardia 7 7
Hematoma 7 7
Embolism/Embolus 7 7
Unspecified Tissue Injury 6 6
Pericarditis 5 5
Ischemia 5 5
Device Embedded In Tissue or Plaque 4 4
Ischemic Heart Disease 3 3
Pulmonary Edema 3 3
No Known Impact Or Consequence To Patient 3 3
Pseudoaneurysm 3 3
Restenosis 3 3
Rupture 2 2
Failure of Implant 2 2
Hypersensitivity/Allergic reaction 2 2
Cardiac Enzyme Elevation 2 2
Cardiogenic Shock 2 2
Great Vessel Perforation 2 2
Discomfort 2 2
Atrial Fibrillation 2 2
No Patient Involvement 1 1
Dyspnea 1 1
Unintended Radiation Exposure 1 1
Aneurysm 1 1
Cough 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL, LLC I Jun-13-2026
2 Acist Medical Systems I Mar-04-2021
3 Boston Scientific Corporation II Mar-28-2024
4 Conavi Medical Inc. I Apr-23-2025
5 Volcano Corp II Jul-30-2025
6 Volcano Corp III Jun-29-2022
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