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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 3
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 3
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 4
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 3
BEIJING DEMAX MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
BIOCARDIA
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 3
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 3
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
INNEUROCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
INQUIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JUPITER ENDOVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROTARYX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PULNOVO MEDICAL (WUXI) CO., LTD.
  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 2
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TALON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  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
2021 2835 3054
2022 4084 8487
2023 3775 7899
2024 3931 7936
2025 4594 8592
2026 2454 3511

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 3249 3249
Adverse Event Without Identified Device or Use Problem 2931 12400
Material Separation 2792 2819
Gas/Air Leak 1586 1587
Material Split, Cut or Torn 1342 1345
Break 1207 1419
Detachment of Device or Device Component 961 961
Material Deformation 916 921
Patient Device Interaction Problem 789 790
Backflow 703 703
Physical Resistance/Sticking 696 697
Material Puncture/Hole 629 629
Device-Device Incompatibility 542 542
Difficult to Insert 534 535
Peeled/Delaminated 522 524
Difficult to Advance 477 482
Leak/Splash 393 465
Failure to Advance 381 381
Unraveled Material 345 346
Difficult to Remove 315 326
Obstruction of Flow 315 315
Insufficient Information 308 8415
Material Integrity Problem 297 297
Material Twisted/Bent 244 244
Fracture 239 240
Use of Device Problem 239 239
Material Frayed 210 210
Flaked 210 210
Deformation Due to Compressive Stress 202 204
Appropriate Term/Code Not Available 183 183
Contamination /Decontamination Problem 177 177
Material Too Rigid or Stiff 153 153
Defective Component 131 147
Patient-Device Incompatibility 131 132
Improper or Incorrect Procedure or Method 113 113
Mechanical Problem 96 96
Defective Device 93 94
Material Protrusion/Extrusion 92 92
Crack 90 91
Activation, Positioning or Separation Problem 89 89
Manufacturing, Packaging or Shipping Problem 84 84
Entrapment of Device 82 82
Positioning Problem 76 77
Air/Gas in Device 74 74
No Apparent Adverse Event 69 69
Partial Blockage 61 61
Component Misassembled 58 58
Stretched 53 53
Device Contaminated During Manufacture or Shipping 50 50
Device Damaged by Another Device 49 49

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14917 14934
Vascular Dissection 1120 1419
Hemorrhage/Bleeding 1058 2867
Insufficient Information 779 825
Foreign Body In Patient 624 627
Perforation of Vessels 460 461
Hematoma 459 2040
Unspecified Vascular Problem 438 8417
Cardiac Perforation 395 396
Pericardial Effusion 361 366
Cardiac Tamponade 320 322
Low Blood Pressure/ Hypotension 281 283
Thrombosis/Thrombus 201 201
Air Embolism 179 180
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 161 5177
Pseudoaneurysm 159 159
Retroperitoneal Hemorrhage 140 1047
Cardiac Arrest 119 119
Obstruction/Occlusion 116 116
Arrhythmia 113 113
No Consequences Or Impact To Patient 96 245
Ischemia 95 95
Perforation 93 95
Pain 91 92
Embolism/Embolus 87 88
Stroke/CVA 83 83
Unspecified Infection 70 88
Rupture 70 70
Fistula 68 68
Thromboembolism 62 62
Bacterial Infection 59 83
Aneurysm 58 60
Device Embedded In Tissue or Plaque 50 52
Great Vessel Perforation 48 48
Unspecified Tissue Injury 48 49
Foreign Body Embolism 43 43
Heart Block 39 39
Tachycardia 32 32
Stenosis 31 31
Cramp(s) /Muscle Spasm(s) 28 28
Asystole 27 28
Pulmonary Embolism 27 27
Swelling/ Edema 25 25
Cardiovascular Insufficiency 24 24
Bradycardia 24 24
Ischemic Heart Disease 24 24
Ventricular Fibrillation 22 22
Pericarditis 21 21
Non specific EKG/ECG Changes 21 21
Anemia 21 21

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Dec-27-2021
2 Abiomed, Inc. II Jan-05-2024
3 Abiomed, Inc. II Jul-11-2023
4 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-21-2021
5 Argon Medical Devices, Inc II Sep-21-2021
6 Argon Medical Devices, Inc II Feb-05-2021
7 Becton, Dickinson and Company II May-15-2026
8 Biosense Webster, Inc. II Sep-02-2022
9 Biosense Webster, Inc. II Mar-22-2021
10 Biosense Webster, Inc. II Mar-13-2024
11 Biosense Webster, Inc. II Apr-01-2023
12 Boston Scientific Corporation II Mar-28-2024
13 Contract Medical International GmbH II Sep-05-2025
14 Cook Inc. II Dec-16-2021
15 Cook Inc. II Oct-29-2021
16 Cook Incorporated II Dec-23-2025
17 Cook Incorporated II May-16-2025
18 Cook Incorporated II Oct-09-2024
19 Cook Incorporated II Apr-12-2024
20 Creganna Medical Devices II Jul-28-2023
21 Datascope Corp. II Jul-21-2023
22 Freudenberg Medical, Llc II Apr-28-2022
23 Galt Medical Corporation II May-07-2025
24 Galt Medical Corporation II Jun-15-2023
25 MEDLINE INDUSTRIES, LP - Northfield II Jan-29-2025
26 Merit Medical Systems, Inc. I Mar-26-2026
27 Merit Medical Systems, Inc. II Mar-24-2025
28 Merit Medical Systems, Inc. II Aug-12-2024
29 Merit Medical Systems, Inc. II Jun-27-2024
30 Merit Medical Systems, Inc. II May-20-2024
31 Merit Medical Systems, Inc. II May-10-2023
32 Merit Medical Systems, Inc. II Aug-12-2021
33 Merit Medical Systems, Inc. II Aug-10-2021
34 Oscor Inc. II Feb-17-2022
35 Oscor, Inc. II Apr-01-2021
36 St. Jude Medical II Jul-12-2024
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