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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous
Regulation Description Percutaneous catheter.
Product CodeDQY
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
ALEMBIC, LLC
  SUBSTANTIALLY EQUIVALENT 3
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BASIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CENTERPOINT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 5
CORDIS US CORP
  SUBSTANTIALLY EQUIVALENT 1
CRUZAR MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EOSOLUTIONS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
HAOLANG MEDICAL USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HEXACATH
  SUBSTANTIALLY EQUIVALENT 1
IMDS OPERATIONS B.V.
  SUBSTANTIALLY EQUIVALENT 5
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARVAO MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, IRELAND
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUTICS INC., D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 2
OKAMI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PENDRACARE
  SUBSTANTIALLY EQUIVALENT 1
REFLOW MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
REFLOW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCIENTIA VASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEIGLA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHOCKWAVE MEDICAL., INC.
  SUBSTANTIALLY EQUIVALENT 1
SIMPSON INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRAIT ACCESS TECHNOLOGIES HOLDINGS
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS,INC.
  SUBSTANTIALLY EQUIVALENT 2
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRANSIT SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 2
TRAVERSE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRISALUS LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
VANTIS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 3
W.L. GORE & ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3006 3017
2022 2643 2667
2023 3049 3126
2024 3191 3206
2025 3098 3098

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2679 2682
Adverse Event Without Identified Device or Use Problem 2648 2733
Break 1091 1099
Material Deformation 842 845
Deformation Due to Compressive Stress 773 773
Detachment of Device or Device Component 733 737
Material Separation 722 723
Physical Resistance/Sticking 693 694
Material Twisted/Bent 691 692
Leak/Splash 645 646
Difficult to Remove 549 552
Fracture 452 452
Fluid/Blood Leak 452 454
Material Integrity Problem 418 425
Difficult to Advance 372 373
Material Split, Cut or Torn 308 308
Unraveled Material 306 306
Crack 282 282
Deflation Problem 275 276
Inflation Problem 198 198
Entrapment of Device 185 185
Accessory Incompatible 178 182
Failure to Advance 156 156
Obstruction of Flow 155 155
Peeled/Delaminated 152 152
Burst Container or Vessel 146 148
Insufficient Information 134 135
Material Frayed 130 130
Material Puncture/Hole 125 125
Use of Device Problem 121 123
Device Dislodged or Dislocated 115 115
Difficult to Insert 101 101
Incorrect, Inadequate or Imprecise Result or Readings 100 100
Air/Gas in Device 94 96
Mechanical Problem 91 92
Packaging Problem 88 90
Device-Device Incompatibility 86 86
Stretched 81 81
Device Damaged by Another Device 77 77
Unable to Obtain Readings 72 72
Improper or Incorrect Procedure or Method 72 73
Retraction Problem 67 68
Appropriate Term/Code Not Available 66 68
Patient Device Interaction Problem 62 63
Positioning Problem 56 56
Failure to Deflate 54 54
No Apparent Adverse Event 54 57
Material Protrusion/Extrusion 50 50
Tear, Rip or Hole in Device Packaging 44 44
Gas/Air Leak 44 44

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10327 10360
Insufficient Information 859 861
Thrombosis/Thrombus 511 513
Foreign Body In Patient 469 475
Pericardial Effusion 462 465
Vascular Dissection 387 391
Low Blood Pressure/ Hypotension 311 311
Hemorrhage/Bleeding 299 366
Intracranial Hemorrhage 250 315
Hematoma 248 311
Cardiac Perforation 237 238
Cardiac Tamponade 214 214
Perforation of Vessels 178 181
Stroke/CVA 169 170
Air Embolism 158 160
Obstruction/Occlusion 148 148
Non specific EKG/ECG Changes 134 136
Embolism/Embolus 128 129
Vasoconstriction 127 131
Perforation 119 121
Ischemia Stroke 111 111
No Consequences Or Impact To Patient 106 106
Cardiac Arrest 99 102
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 99 99
Device Embedded In Tissue or Plaque 88 90
Unspecified Nervous System Problem 71 71
Swelling/ Edema 71 71
Pain 70 70
Thromboembolism 69 69
Rupture 69 69
Ischemia 69 70
Pseudoaneurysm 68 69
Bradycardia 60 61
Myocardial Infarction 56 56
Arrhythmia 55 56
Stenosis 49 50
Unspecified Tissue Injury 46 46
Ruptured Aneurysm 40 40
Discomfort 36 36
Transient Ischemic Attack 35 36
Heart Block 34 38
High Blood Pressure/ Hypertension 33 33
Tachycardia 31 32
Headache 29 29
Needle Stick/Puncture 29 29
Restenosis 27 27
Hemorrhagic Stroke 27 27
Aneurysm 27 27
Muscle Weakness 27 27
Chest Pain 26 27

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Apr-21-2025
2 Abbott I Jul-11-2023
3 Abbott II Apr-07-2022
4 BALT USA, LLC I Oct-24-2025
5 Boston Scientific Corporation I Aug-29-2025
6 Boston Scientific Corporation II Oct-03-2023
7 Boston Scientific Corporation II Aug-25-2022
8 Boston Scientific Corporation II Apr-15-2021
9 Boston Scientific Corporation II Jan-15-2021
10 Cook Incorporated II Jul-08-2022
11 Cordis US Corp II Mar-13-2025
12 MICROVENTION INC. II Jan-17-2025
13 MICROVENTION INC. III Jun-07-2021
14 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
15 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
16 Medtronic Vascular II Mar-11-2021
17 Merit Medical Systems, Inc. II Jan-02-2024
18 Mivi Neuroscience Inc II Sep-09-2021
19 ROUTE 92 MEDICAL INC I Apr-24-2024
20 Scientia Vascular, Inc. II Mar-13-2023
21 Stryker Neurovascular II May-28-2024
22 Stryker Neurovascular II May-01-2024
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