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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 4
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 7
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 OPERATION B.V.
  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
  1.  K210188  coraCross
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 3188 3203
2025 3096 3096
2026 1970 1970

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2997 3082
Material Rupture 2741 2744
Break 1171 1176
Material Deformation 886 889
Deformation Due to Compressive Stress 861 861
Material Twisted/Bent 812 812
Material Separation 810 811
Detachment of Device or Device Component 800 803
Leak/Splash 799 800
Difficult to Remove 750 753
Physical Resistance/Sticking 716 717
Fracture 523 523
Fluid/Blood Leak 503 505
Material Integrity Problem 488 495
Difficult to Advance 416 417
Material Split, Cut or Torn 348 348
Unraveled Material 328 328
Crack 325 325
Deflation Problem 276 277
Accessory Incompatible 213 217
Inflation Problem 210 210
Peeled/Delaminated 192 192
Entrapment of Device 181 181
Obstruction of Flow 180 180
Difficult to Insert 175 175
Failure to Advance 173 173
Insufficient Device Problem Information 163 164
Burst Container or Vessel 158 160
Air/Gas in Device 152 154
Material Puncture/Hole 139 139
Use of Device Problem 137 139
Device Dislodged or Dislocated 126 126
Material Frayed 123 123
Incorrect, Inadequate or Imprecise Result or Readings 108 108
Mechanical Problem 105 105
Device-Device Incompatibility 101 101
Packaging Problem 93 95
Unable to Obtain Readings 84 84
Stretched 84 84
Device Damaged by Another Device 83 83
Appropriate Device Problem Term/Code Not Available 81 83
Retraction Problem 81 82
Improper or Incorrect Procedure or Method 79 80
Material Protrusion/Extrusion 66 66
No Apparent Adverse Event 65 68
Positioning Problem 64 64
Patient Device Interaction Problem 64 65
Unintended Movement 61 61
Failure to Deflate 55 55
Gas/Air Leak 50 50

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11711 11744
Insufficient Information 949 951
Thrombosis/Thrombus 600 602
Pericardial Effusion 577 580
Foreign Body In Patient 526 532
Vascular Dissection 414 418
Low Blood Pressure/ Hypotension 395 395
Hemorrhage/Blood Loss/Bleeding 352 419
Cardiac Perforation 292 293
Hematoma 277 340
Intracranial Hemorrhage 265 330
Cardiac Tamponade 261 261
Perforation of Vessels 198 201
Air Embolism 189 191
Stroke/CVA 180 181
Non specific EKG/ECG Changes 159 161
Obstruction/Occlusion 153 153
Embolism/Embolus 137 138
Perforation 135 137
Vasoconstriction 131 135
Ischemia Stroke 126 126
Cardiac Arrest 121 124
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 96 98
Swelling/ Edema 78 78
Pain 78 78
Ischemia 74 75
Unspecified Nervous System Problem 72 72
Rupture 71 71
Thromboembolism 70 70
Pseudoaneurysm 69 70
Bradycardia 66 67
Myocardial Infarction 62 62
Arrhythmia 62 63
Unspecified Tissue Injury 57 57
Stenosis 52 53
Ruptured Aneurysm 47 47
Heart Block 40 44
Discomfort 39 39
Tachycardia 38 39
Transient Ischemic Attack 36 37
Headache 34 34
High Blood Pressure/ Hypertension 34 34
Hemorrhagic Stroke 32 32
Chest Pain 32 33
Needle Stick/Puncture 32 32
Muscle Weakness/Atrophy 32 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 Aug-07-2026
14 MICROVENTION INC. II Jan-17-2025
15 MICROVENTION INC. III Jun-07-2021
16 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
17 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
18 Medtronic Vascular II Mar-11-2021
19 Merit Medical Systems, Inc. II Jan-02-2024
20 Mivi Neuroscience Inc II Sep-09-2021
21 ROUTE 92 MEDICAL INC I Apr-24-2024
22 Scientia Vascular, Inc. II Mar-13-2023
23 Stryker Neurovascular II May-28-2024
24 Stryker Neurovascular II May-01-2024
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