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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device introducer, catheter
Regulation Description Catheter introducer.
Product CodeDYB
Regulation Number 870.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
ABIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 6
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 2
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 3
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 5
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 6
BEIJING DEMAX MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
BIOCARDIA
  SUBSTANTIALLY EQUIVALENT 1
BIOCARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOCYCLE MEDICAL(SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOVIA , LTD.
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 6
CIRCA SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONTRACT MEDICAL INTERNATIONAL, GMBH
  SUBSTANTIALLY EQUIVALENT 5
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 5
COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CORDIS US CORP
  SUBSTANTIALLY EQUIVALENT 1
CULTIV8 1, LLC
  SUBSTANTIALLY EQUIVALENT 1
CURATIA MEDICAL CO.
  SUBSTANTIALLY EQUIVALENT 1
DIB ULTRANAV MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EAST END MEDICAL I, LLC
  SUBSTANTIALLY EQUIVALENT 2
ECHO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 4
ENDOPHYS HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 2
FREUDENBERG MEDICAL MIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FREUDENBERG MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
GREAT BATCH MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
INNEUROCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
INQUIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JUPITER ENDOVASCULAR
  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 4
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENDRACARE
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
PROTARYX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PULNOVO MEDICAL (WUXI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RAM MEDICAL INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SONOSTIK, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOUTH53, LLC
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS,INC.
  SUBSTANTIALLY EQUIVALENT 3
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TALON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL COPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRANSAORTIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRANSSEPTAL SOLUTIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCUTECH MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VIVASURE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VIZARAMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZOLL RESPICARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1903 1904
2019 2450 2450
2020 2465 2479
2021 2835 3054
2022 4084 8487
2023 3775 7899
2024 3931 7936
2025 4594 8592
2026 2896 3959

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 3956 3956
Adverse Event Without Identified Device or Use Problem 3833 13302
Material Separation 3518 3544
Gas/Air Leak 1869 1870
Detachment of Device or Device Component 1646 1646
Material Split, Cut or Torn 1475 1478
Break 1446 1643
Material Deformation 1218 1222
Patient Device Interaction Problem 852 858
Backflow 768 768
Physical Resistance/Sticking 766 766
Leak/Splash 762 832
Material Puncture/Hole 724 724
Difficult to Insert 699 700
Difficult to Advance 586 591
Peeled/Delaminated 565 567
Device-Device Incompatibility 555 555
Unraveled Material 444 444
Failure to Advance 411 411
Difficult to Remove 381 391
Flaked 349 349
Component Misassembled 345 345
Insufficient Device Problem Information 345 8452
Material Integrity Problem 345 345
Fracture 345 346
Obstruction of Flow 330 330
Use of Device Problem 315 315
Material Frayed 280 280
Material Twisted/Bent 256 256
Contamination /Decontamination Problem 240 240
Appropriate Device Problem Term/Code Not Available 234 234
Deformation Due to Compressive Stress 227 230
Patient-Device Incompatibility 186 187
Material Too Rigid or Stiff 159 159
Defective Component 150 166
Improper or Incorrect Procedure or Method 143 143
Device Contamination with Chemical or Other Material 135 135
Crack 120 121
Activation, Positioning or Separation Problem 108 108
Mechanical Problem 105 105
Material Protrusion/Extrusion 94 94
Manufacturing, Packaging or Shipping Problem 89 89
Stretched 86 86
Separation Problem 84 84
Positioning Problem 79 80
Device Contaminated During Manufacture or Shipping 77 77
No Apparent Adverse Event 75 75
Defective Device 75 76
Material Perforation 73 73
Air/Gas in Device 71 71

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15577 15597
No Consequences Or Impact To Patient 3212 3361
Vascular Dissection 1335 1634
Hemorrhage/Blood Loss/Bleeding 1177 2986
No Known Impact Or Consequence To Patient 825 837
Insufficient Information 821 867
Foreign Body In Patient 758 761
Cardiac Perforation 730 731
Perforation of Vessels 582 583
Hematoma 562 2143
Unspecified Vascular Problem 442 8426
Blood Loss 434 439
Pericardial Effusion 410 415
No Patient Involvement 396 402
Cardiac Tamponade 370 372
Low Blood Pressure/ Hypotension 315 317
No Code Available 313 313
Air Embolism 216 217
Thrombosis/Thrombus 206 206
Device Embedded In Tissue or Plaque 200 202
Pseudoaneurysm 195 195
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 163 5179
Retroperitoneal Hemorrhage 141 1048
Cardiac Arrest 138 138
Stroke/CVA 137 137
Arrhythmia 133 133
Perforation 131 133
Death 127 127
Ischemia 124 124
Pain 123 124
Obstruction/Occlusion 119 119
Aneurysm 112 114
Fistula 92 92
Embolism/Embolus 90 91
No Information 90 90
Unspecified Infection 85 103
Rupture 75 75
Thromboembolism 67 67
Bacterial Infection 59 83
Great Vessel Perforation 53 53
Unspecified Tissue Injury 50 51
Foreign Body Embolism 44 44
Stenosis 40 40
Heart Block 39 39
Tachycardia 35 35
Needle Stick/Puncture 34 34
Pulmonary Embolism 32 32
Myocardial Infarction 32 32
Cramp(s) /Muscle Spasm(s) 31 31
Bradycardia 29 29

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL, LLC I Jun-13-2026
2 Abbott II Dec-27-2021
3 Abbott Medical II Jan-08-2020
4 Abbott Medical II Jan-07-2020
5 Abiomed, Inc. I Jul-10-2026
6 Abiomed, Inc. I Jun-25-2026
7 Abiomed, Inc. II Jan-05-2024
8 Abiomed, Inc. II Jul-11-2023
9 Acutus Medical Inc II Apr-23-2020
10 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-21-2021
11 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
12 Argon Medical Devices, Inc II Sep-21-2021
13 Argon Medical Devices, Inc II Feb-05-2021
14 Arrow International Inc II Feb-14-2020
15 Arrow International Inc II Sep-23-2019
16 Arrow International Inc II Jul-30-2018
17 Arrow International Inc II May-30-2018
18 Arrow International Inc II Apr-10-2018
19 Arrow International Inc II Apr-02-2018
20 Arrow International Inc II Mar-05-2018
21 Baylis Medical Company Inc. II May-21-2020
22 Becton, Dickinson and Company II May-15-2026
23 Biosense Webster, Inc. II Sep-02-2022
24 Biosense Webster, Inc. II Mar-22-2021
25 Biosense Webster, Inc. II Mar-13-2024
26 Biosense Webster, Inc. II Apr-01-2023
27 Boston Scientific Corporation II Mar-28-2024
28 Contract Medical International GmbH II Sep-05-2025
29 Cook Inc. II Dec-16-2021
30 Cook Inc. II Oct-29-2021
31 Cook Inc. I Dec-23-2020
32 Cook Inc. II Feb-20-2019
33 Cook Incorporated II Dec-23-2025
34 Cook Incorporated II May-16-2025
35 Cook Incorporated II Oct-09-2024
36 Cook Incorporated II Apr-12-2024
37 Creganna Medical Devices II Jul-28-2023
38 Datascope Corp. II Jul-21-2023
39 Freudenberg Medical, Llc II Apr-28-2022
40 Galt Medical Corporation II May-07-2025
41 Galt Medical Corporation II Jun-15-2023
42 Galt Medical Corporation II Jul-27-2018
43 Kalila Medical II Feb-09-2018
44 MEDLINE INDUSTRIES, LP - Northfield II Jan-29-2025
45 Medtronic Vascular Galway DBA Medtronic Ireland I May-27-2020
46 Merit Medical Systems, Inc. I Mar-26-2026
47 Merit Medical Systems, Inc. II Mar-24-2025
48 Merit Medical Systems, Inc. II Aug-12-2024
49 Merit Medical Systems, Inc. II Jun-27-2024
50 Merit Medical Systems, Inc. II May-20-2024
51 Merit Medical Systems, Inc. II May-10-2023
52 Merit Medical Systems, Inc. II Aug-12-2021
53 Merit Medical Systems, Inc. II Aug-10-2021
54 Merit Medical Systems, Inc. II May-11-2020
55 Merit Medical Systems, Inc. II Feb-22-2018
56 Oscor Inc. I Jul-10-2026
57 Oscor Inc. II Feb-17-2022
58 Oscor, Inc. II Apr-01-2021
59 St. Jude Medical II Jul-12-2024
60 Terumo Medical Corporation I May-28-2019
61 Terumo Medical Corporation II Feb-26-2018
62 W. L. Gore & Associates Inc. II May-11-2020
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