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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 (ST. JUDE MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
ALEMBIC, LLC
  SUBSTANTIALLY EQUIVALENT 3
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BASIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIOCARDIA
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 7
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 3
MEDTRONIC, IRELAND
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 3
MIVI NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
NITILOOP , LTD.
  SUBSTANTIALLY EQUIVALENT 1
OKAMI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K231608  Teleport XT Microcatheter
  2.  K242588  COREPASS Modular Microcatheter (FLEX); COREPASS Mo ...
PENDRACARE
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
QXMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
REFLOW MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
REFLOW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ROUTE 92 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
  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 4
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
2020 2889 2891
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 3365 3368
Adverse Event Without Identified Device or Use Problem 2944 3031
Break 1369 1377
Material Deformation 1163 1166
Detachment of Device or Device Component 961 965
Physical Resistance/Sticking 893 894
Deformation Due to Compressive Stress 807 807
Material Separation 789 790
Leak/Splash 736 737
Material Twisted/Bent 729 730
Difficult to Remove 633 636
Fracture 515 515
Fluid/Blood Leak 512 514
Material Integrity Problem 478 485
Difficult to Advance 415 416
Deflation Problem 380 381
Material Split, Cut or Torn 373 373
Unraveled Material 360 360
Crack 341 341
Failure to Advance 272 272
Inflation Problem 250 250
Entrapment of Device 226 226
Peeled/Delaminated 200 200
Burst Container or Vessel 200 202
Accessory Incompatible 186 190
Material Frayed 167 167
Obstruction of Flow 161 161
Material Puncture/Hole 158 158
Insufficient Information 144 145
Difficult to Insert 140 140
Retraction Problem 137 138
Use of Device Problem 128 130
Device Dislodged or Dislocated 125 125
Mechanical Problem 107 108
Incorrect, Inadequate or Imprecise Result or Readings 100 100
Device-Device Incompatibility 98 98
Device Damaged by Another Device 97 97
Packaging Problem 96 98
Air/Gas in Device 94 96
Stretched 90 90
Improper or Incorrect Procedure or Method 87 88
Unable to Obtain Readings 80 80
Appropriate Term/Code Not Available 73 75
Patient Device Interaction Problem 64 65
Device Damaged Prior to Use 61 61
Device Contamination with Chemical or Other Material 60 60
Positioning Problem 60 60
No Apparent Adverse Event 59 62
Failure to Deflate 55 55
Material Fragmentation 52 52

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10672 10705
No Consequences Or Impact To Patient 1912 1912
Insufficient Information 880 883
Thrombosis/Thrombus 513 515
Foreign Body In Patient 505 511
Pericardial Effusion 504 507
Vascular Dissection 478 482
Low Blood Pressure/ Hypotension 327 327
Hemorrhage/Bleeding 318 385
Hematoma 275 338
Cardiac Perforation 257 258
No Known Impact Or Consequence To Patient 257 257
Intracranial Hemorrhage 255 320
Cardiac Tamponade 238 238
Perforation of Vessels 225 228
Stroke/CVA 188 189
Air Embolism 170 172
Obstruction/Occlusion 160 161
Device Embedded In Tissue or Plaque 146 148
Vasoconstriction 142 147
Embolism/Embolus 141 142
Perforation 134 136
Non specific EKG/ECG Changes 134 136
Ischemia Stroke 111 111
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 111 111
Cardiac Arrest 108 111
No Patient Involvement 93 93
Rupture 83 83
Thromboembolism 78 79
Pseudoaneurysm 76 77
Swelling/ Edema 73 74
Unspecified Nervous System Problem 72 72
Pain 70 70
Ischemia 69 70
Myocardial Infarction 65 65
Bradycardia 62 63
Arrhythmia 58 59
Stenosis 50 51
Unspecified Tissue Injury 46 46
Ruptured Aneurysm 43 43
Death 40 41
Aneurysm 40 40
Discomfort 39 39
Transient Ischemic Attack 36 37
No Code Available 34 34
Heart Block 34 38
High Blood Pressure/ Hypertension 34 34
Tachycardia 32 33
Needle Stick/Puncture 31 31
Headache 30 30

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 Arrow International Inc II Feb-14-2020
5 BALT USA, LLC I Oct-24-2025
6 Bard Peripheral Vascular Inc II Oct-08-2020
7 Boston Scientific Corporation I Aug-29-2025
8 Boston Scientific Corporation II Oct-03-2023
9 Boston Scientific Corporation II Aug-25-2022
10 Boston Scientific Corporation II Apr-15-2021
11 Boston Scientific Corporation II Jan-15-2021
12 Cook Inc. II Jun-02-2020
13 Cook Incorporated II Jul-08-2022
14 Cordis US Corp II Mar-13-2025
15 MICROVENTION INC. II Jan-17-2025
16 MICROVENTION INC. III Jun-07-2021
17 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
18 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
19 Medtronic Vascular II Mar-11-2021
20 Merit Medical Systems, Inc. II Jan-02-2024
21 Mivi Neuroscience Inc II Sep-09-2021
22 ROUTE 92 MEDICAL INC I Apr-24-2024
23 Scientia Vascular, Inc. II Mar-13-2023
24 Stryker Neurovascular II May-28-2024
25 Stryker Neurovascular II May-01-2024
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