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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
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 12
ALEMBIC, LLC
  SUBSTANTIALLY EQUIVALENT 3
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BALOSMARK, INC.
  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 LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 2
OKAMI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
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 3005 3016
2022 2643 2667
2023 3049 3126
2024 3189 3204
2025 3096 3096
2026 1672 1672

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2942 3027
Material Rupture 2722 2725
Break 1152 1157
Material Deformation 878 881
Deformation Due to Compressive Stress 850 850
Material Separation 785 786
Material Twisted/Bent 782 782
Leak/Splash 780 781
Detachment of Device or Device Component 780 783
Difficult to Remove 732 735
Physical Resistance/Sticking 709 710
Fracture 508 508
Fluid/Blood Leak 497 499
Material Integrity Problem 481 488
Difficult to Advance 410 411
Material Split, Cut or Torn 339 339
Unraveled Material 320 320
Crack 313 313
Deflation Problem 277 278
Inflation Problem 206 206
Accessory Incompatible 206 210
Peeled/Delaminated 182 182
Entrapment of Device 180 180
Obstruction of Flow 175 175
Failure to Advance 171 171
Difficult to Insert 169 169
Burst Container or Vessel 156 158
Insufficient Device Problem Information 152 153
Air/Gas in Device 140 142
Material Puncture/Hole 136 136
Use of Device Problem 132 134
Device Dislodged or Dislocated 124 124
Material Frayed 123 123
Incorrect, Inadequate or Imprecise Result or Readings 108 108
Mechanical Problem 104 104
Device-Device Incompatibility 100 100
Packaging Problem 93 95
Unable to Obtain Readings 84 84
Stretched 82 82
Appropriate Device Problem Term/Code Not Available 80 82
Device Damaged by Another Device 80 80
Retraction Problem 79 80
Improper or Incorrect Procedure or Method 78 79
Material Protrusion/Extrusion 66 66
Positioning Problem 64 64
No Apparent Adverse Event 64 67
Patient Device Interaction Problem 64 65
Unintended Movement 59 59
Failure to Deflate 54 54
Gas/Air Leak 49 49

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11513 11546
Insufficient Information 924 926
Thrombosis/Thrombus 591 593
Pericardial Effusion 557 560
Foreign Body In Patient 513 519
Vascular Dissection 410 414
Low Blood Pressure/ Hypotension 384 384
Hemorrhage/Blood Loss/Bleeding 344 411
Cardiac Perforation 280 281
Hematoma 268 331
Intracranial Hemorrhage 264 329
Cardiac Tamponade 253 253
Perforation of Vessels 196 199
Air Embolism 184 186
Stroke/CVA 180 181
Obstruction/Occlusion 153 153
Non specific EKG/ECG Changes 151 153
Perforation 135 137
Embolism/Embolus 135 136
Vasoconstriction 130 134
Ischemia Stroke 125 125
Cardiac Arrest 119 122
No Consequences Or Impact To Patient 106 106
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 101 101
Device Embedded In Tissue or Plaque 94 96
Pain 78 78
Swelling/ Edema 77 77
Ischemia 74 75
Unspecified Nervous System Problem 72 72
Rupture 71 71
Thromboembolism 70 70
Pseudoaneurysm 69 70
Bradycardia 65 66
Myocardial Infarction 62 62
Arrhythmia 62 63
Unspecified Tissue Injury 57 57
Stenosis 52 53
Ruptured Aneurysm 46 46
Heart Block 40 44
Discomfort 39 39
Tachycardia 38 39
Transient Ischemic Attack 35 36
High Blood Pressure/ Hypertension 34 34
Headache 33 33
Muscle Weakness/Atrophy 32 32
Needle Stick/Puncture 32 32
Hemorrhagic Stroke 32 32
Chest Pain 31 32
Aneurysm 30 30
Restenosis 29 29

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL, LLC I Jun-13-2026
2 Abbott II Apr-21-2025
3 Abbott I Jul-11-2023
4 Abbott II Apr-07-2022
5 BALT USA, LLC I Oct-24-2025
6 Boston Scientific Corporation I Aug-29-2025
7 Boston Scientific Corporation II Oct-03-2023
8 Boston Scientific Corporation II Aug-25-2022
9 Boston Scientific Corporation II Apr-15-2021
10 Boston Scientific Corporation II Jan-15-2021
11 Cook Incorporated II Jul-08-2022
12 Cordis US Corp II Mar-13-2025
13 MICROVENTION INC. II Jan-17-2025
14 MICROVENTION INC. III Jun-07-2021
15 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
16 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
17 Medtronic Vascular II Mar-11-2021
18 Merit Medical Systems, Inc. II Jan-02-2024
19 Mivi Neuroscience Inc II Sep-09-2021
20 ROUTE 92 MEDICAL INC I Apr-24-2024
21 Scientia Vascular, Inc. II Mar-13-2023
22 Stryker Neurovascular II May-28-2024
23 Stryker Neurovascular II May-01-2024
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