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 introducer, catheter
Product CodeDYB
Regulation Number 870.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ABIOMED INC.
  SUBSTANTIALLY EQUIVALENT 3
ABIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 2
ACUTUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 3
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BARD PERIPHERAL VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 5
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOCARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R.BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
CONTRACT MEDICAL INTERNATIONAL GMBH
  SUBSTANTIALLY EQUIVALENT 3
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 5
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
CURATIA MEDICAL CO.
  SUBSTANTIALLY EQUIVALENT 1
DIB ULTRANAV MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EAST END MEDICAL I LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
ENDOPHYS HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
ENDOPHYS HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
FREUDENBERG MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
FREUDENBERG MEDICAL MIS, INC
  SUBSTANTIALLY EQUIVALENT 1
GREATBATCH MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KEYSTONE HEART, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT - KIT 1
MERIT MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
RAM MEDICAL INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TALON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL COPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TRANSAORTIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRANSSEPTAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIZARAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1903 1903
2019 2449 2449
2020 2465 2465
2021 2834 3044
2022 4084 8472
2023 2558 4408

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2679 2704
Adverse Event Without Identified Device or Use Problem 2149 5293
Fluid/Blood Leak 1986 1986
Detachment of Device or Device Component 1279 1279
Break 1000 1210
Material Deformation 780 780
Gas/Air Leak 655 655
Leak/Splash 593 664
Material Split, Cut or Torn 485 485
Difficult to Insert 412 412
Device-Device Incompatibility 349 349
Component Misassembled 332 332
Physical Resistance/Sticking 321 321
Difficult to Advance 319 319
Unraveled Material 319 319
Backflow 316 316
Obstruction of Flow 298 298
Material Puncture/Hole 285 285
Difficult to Remove 264 273
Failure to Advance 257 257
Fracture 255 255
Flaked 244 244
Patient Device Interaction Problem 216 216
Peeled/Delaminated 211 211
Insufficient Information 200 3304
Material Frayed 185 185
Patient-Device Incompatibility 176 176
Material Twisted/Bent 167 167
Contamination /Decontamination Problem 166 166
Material Integrity Problem 162 162
Appropriate Term/Code Not Available 160 160
Device Contamination with Chemical or Other Material 130 130
Use of Device Problem 125 125
Defective Component 100 115
Entrapment of Device 94 94
Deformation Due to Compressive Stress 92 92
Improper or Incorrect Procedure or Method 88 88
Crack 72 72
Separation Problem 69 69
Activation, Positioning or Separation Problem 68 68
Stretched 67 67
Material Fragmentation 66 66
Detachment Of Device Component 60 60
Device Contaminated During Manufacture or Shipping 51 51
Mechanical Problem 47 47
Material Too Rigid or Stiff 46 46
Defective Device 44 44
Connection Problem 43 43
Air Leak 41 41
Air/Gas in Device 41 41
Material Perforation 39 39
Material Protrusion/Extrusion 38 38
Device Contamination with Body Fluid 37 37
Device Damaged Prior to Use 36 36
Device Damaged by Another Device 36 36
Positioning Problem 35 35
Device Dislodged or Dislocated 32 32
No Apparent Adverse Event 31 31
Packaging Problem 30 43
Partial Blockage 29 29
Component Missing 28 28
Manufacturing, Packaging or Shipping Problem 28 28
Difficult or Delayed Separation 26 26
Kinked 23 23
Torn Material 21 21
Unsealed Device Packaging 20 20
Device Operates Differently Than Expected 19 19
Scratched Material 19 19
Mechanical Jam 18 18
Split 18 18
Fitting Problem 17 17
Inadequacy of Device Shape and/or Size 17 17
Device Markings/Labelling Problem 17 17
Material Rupture 17 17
Migration 17 17
Sharp Edges 16 16
Unintended Movement 16 16
Loose or Intermittent Connection 16 16
Nonstandard Device 16 16
Delivered as Unsterile Product 16 16
Malposition of Device 16 16
Component Incompatible 15 15
Contamination 15 15
Material Too Soft/Flexible 15 15
Therapeutic or Diagnostic Output Failure 14 14
Accessory Incompatible 14 14
Corroded 13 13
Display or Visual Feedback Problem 13 13
Migration or Expulsion of Device 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Off-Label Use 13 13
Tear, Rip or Hole in Device Packaging 13 13
Protective Measures Problem 13 13
Output Problem 12 12
Difficult or Delayed Positioning 12 12
Retraction Problem 10 10
Loss of or Failure to Bond 8 8
Complete Blockage 8 8
Coagulation in Device or Device Ingredient 8 8
Structural Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6957 6957
No Consequences Or Impact To Patient 3212 3361
No Known Impact Or Consequence To Patient 824 824
Vascular Dissection 688 979
Cardiac Perforation 480 480
Insufficient Information 464 506
Foreign Body In Patient 454 454
Hemorrhage/Bleeding 452 1136
Blood Loss 434 439
No Patient Involvement 396 402
No Code Available 313 313
Hematoma 236 838
Perforation of Vessels 227 227
Pericardial Effusion 185 185
Device Embedded In Tissue or Plaque 181 181
Cardiac Tamponade 164 164
Death 127 127
Unspecified Vascular Problem 113 1373
Low Blood Pressure/ Hypotension 108 108
Air Embolism 106 106
Pseudoaneurysm 105 105
Aneurysm 104 104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 97 3272
No Information 90 90
Stroke/CVA 90 90
Perforation 80 80
Thrombosis/Thrombus 79 79
Cardiac Arrest 65 65
Obstruction/Occlusion 63 63
Pain 62 62
Bacterial Infection 55 79
Unspecified Infection 55 73
Retroperitoneal Hemorrhage 53 310
Fistula 46 46
Rupture 44 44
Arrhythmia 32 32
Thrombosis 29 29
Great Vessel Perforation 26 26
Myocardial Infarction 26 26
Unspecified Tissue Injury 26 26
Embolism/Embolus 26 26
Foreign Body Embolism 26 26
Thromboembolism 26 26
Intimal Dissection 24 24
Heart Block 23 23
Anaphylactic Shock 22 22
Ischemia 21 21
Cardiogenic Shock 21 21
Cramp(s) /Muscle Spasm(s) 21 21
Needle Stick/Puncture 20 20
Thrombus 20 20
Laceration(s) 20 20
Embolism 20 20
Bruise/Contusion 19 49
Stenosis 19 19
Injury 18 18
Tachycardia 18 18
Bradycardia 18 18
Calcium Deposits/Calcification 17 17
Transient Ischemic Attack 17 17
Ventricular Fibrillation 16 16
Occlusion 15 15
Pulmonary Embolism 15 15
Aortic Dissection 15 15
Pneumothorax 14 14
Vasoconstriction 14 14
Chest Pain 13 13
Ischemic Heart Disease 13 13
Paralysis 12 12
Reaction 12 12
Tissue Damage 11 11
Vessel Or Plaque, Device Embedded In 11 11
Atrial Perforation 11 11
Swelling/ Edema 11 11
Cardiovascular Insufficiency 11 11
Hemothorax 10 10
Nerve Damage 10 10
Pleural Effusion 10 10
ST Segment Elevation 9 9
Sepsis 9 9
Atrial Fibrillation 9 9
Non specific EKG/ECG Changes 9 9
Asystole 9 9
Edema 8 8
Dyspnea 7 7
Exposure to Body Fluids 7 19
Anemia 7 7
Embolus 7 7
Inflammation 7 7
Hemostasis 7 7
Swelling 7 7
Hypovolemia 7 7
Dizziness 7 7
Heart Failure/Congestive Heart Failure 7 7
Pericarditis 7 7
Patient Problem/Medical Problem 7 7
Loss of consciousness 6 6
Discomfort 6 6
Hypovolemic Shock 6 6
Erythema 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Dec-27-2021
2 Abbott Medical II Jan-08-2020
3 Abbott Medical II Jan-07-2020
4 Abiomed, Inc. II Jul-11-2023
5 Acutus Medical Inc II Apr-23-2020
6 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-21-2021
7 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
8 Argon Medical Devices, Inc II Sep-21-2021
9 Argon Medical Devices, Inc II Feb-05-2021
10 Arrow International Inc II Feb-14-2020
11 Arrow International Inc II Sep-23-2019
12 Arrow International Inc II Jul-30-2018
13 Arrow International Inc II May-30-2018
14 Arrow International Inc II Apr-10-2018
15 Arrow International Inc II Apr-02-2018
16 Arrow International Inc II Mar-05-2018
17 Baylis Medical Company Inc. II May-21-2020
18 Biosense Webster, Inc. II Sep-02-2022
19 Biosense Webster, Inc. II Mar-22-2021
20 Biosense Webster, Inc. II Apr-01-2023
21 Cook Inc. II Dec-16-2021
22 Cook Inc. II Oct-29-2021
23 Cook Inc. I Dec-23-2020
24 Cook Inc. II Feb-20-2019
25 Creganna Medical Devices II Jul-28-2023
26 Datascope Corp. II Jul-21-2023
27 Freudenberg Medical, Llc II Apr-28-2022
28 Galt Medical Corporation II Jun-15-2023
29 Galt Medical Corporation II Jul-27-2018
30 Kalila Medical II Feb-09-2018
31 Medtronic Vascular Galway DBA Medtronic Ireland I May-27-2020
32 Merit Medical Systems, Inc. II May-10-2023
33 Merit Medical Systems, Inc. II Aug-12-2021
34 Merit Medical Systems, Inc. II Aug-10-2021
35 Merit Medical Systems, Inc. II May-11-2020
36 Merit Medical Systems, Inc. II Feb-22-2018
37 Oscor Inc. II Feb-17-2022
38 Oscor, Inc. II Apr-01-2021
39 Terumo Medical Corporation I May-28-2019
40 Terumo Medical Corporation II Feb-26-2018
41 W. L. Gore & Associates Inc. II May-11-2020
-
-