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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 1
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 11
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 3190 3205
2025 3095 3095
2026 1371 1371

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2902 2987
Material Rupture 2714 2717
Break 1193 1201
Material Deformation 884 887
Deformation Due to Compressive Stress 833 833
Material Twisted/Bent 796 797
Detachment of Device or Device Component 789 793
Material Separation 779 780
Leak/Splash 762 763
Physical Resistance/Sticking 729 730
Difficult to Remove 727 730
Fracture 511 511
Fluid/Blood Leak 492 494
Material Integrity Problem 469 476
Difficult to Advance 402 403
Material Split, Cut or Torn 342 342
Unraveled Material 317 317
Crack 307 307
Deflation Problem 278 279
Inflation Problem 206 206
Accessory Incompatible 199 203
Entrapment of Device 194 194
Failure to Advance 177 177
Peeled/Delaminated 174 174
Obstruction of Flow 170 170
Difficult to Insert 162 162
Burst Container or Vessel 157 159
Insufficient Information 139 140
Material Puncture/Hole 134 134
Air/Gas in Device 133 135
Material Frayed 132 132
Use of Device Problem 130 132
Device Dislodged or Dislocated 126 126
Incorrect, Inadequate or Imprecise Result or Readings 109 109
Mechanical Problem 104 105
Device-Device Incompatibility 96 96
Packaging Problem 93 95
Stretched 85 85
Unable to Obtain Readings 84 84
Device Damaged by Another Device 81 81
Improper or Incorrect Procedure or Method 79 80
Retraction Problem 78 79
Appropriate Term/Code Not Available 77 79
Material Protrusion/Extrusion 66 66
Positioning Problem 66 66
No Apparent Adverse Event 64 67
Patient Device Interaction Problem 64 65
Unintended Movement 54 54
Failure to Deflate 54 54
Gas/Air Leak 50 50

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11293 11326
Insufficient Information 909 911
Thrombosis/Thrombus 577 579
Pericardial Effusion 540 543
Foreign Body In Patient 506 512
Vascular Dissection 406 410
Low Blood Pressure/ Hypotension 375 375
Hemorrhage/Bleeding 333 400
Cardiac Perforation 273 274
Hematoma 263 326
Intracranial Hemorrhage 262 327
Cardiac Tamponade 247 247
Perforation of Vessels 194 197
Air Embolism 180 182
Stroke/CVA 178 179
Obstruction/Occlusion 153 153
Non specific EKG/ECG Changes 149 151
Embolism/Embolus 135 136
Vasoconstriction 130 134
Perforation 130 132
Ischemia Stroke 125 125
Cardiac Arrest 115 118
No Consequences Or Impact To Patient 106 106
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 100 100
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 62 63
Arrhythmia 62 63
Myocardial Infarction 60 60
Unspecified Tissue Injury 52 52
Stenosis 52 53
Ruptured Aneurysm 46 46
Discomfort 39 39
Tachycardia 38 39
Heart Block 37 41
Transient Ischemic Attack 35 36
Headache 34 34
High Blood Pressure/ Hypertension 34 34
Muscle Weakness 32 32
Needle Stick/Puncture 32 32
Hemorrhagic Stroke 31 31
Aneurysm 30 30
Chest Pain 30 31
Restenosis 28 28

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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