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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
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 3096 3096
2026 225 225

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3372 3375
Adverse Event Without Identified Device or Use Problem 2991 3078
Break 1384 1392
Material Deformation 1169 1172
Detachment of Device or Device Component 970 974
Physical Resistance/Sticking 900 901
Deformation Due to Compressive Stress 824 824
Material Separation 798 799
Material Twisted/Bent 757 758
Leak/Splash 748 749
Difficult to Remove 654 657
Fracture 521 521
Fluid/Blood Leak 517 519
Material Integrity Problem 488 495
Difficult to Advance 417 418
Deflation Problem 378 379
Material Split, Cut or Torn 377 377
Unraveled Material 364 364
Crack 343 343
Failure to Advance 274 274
Inflation Problem 252 252
Entrapment of Device 230 230
Peeled/Delaminated 202 202
Burst Container or Vessel 201 203
Accessory Incompatible 190 194
Obstruction of Flow 169 169
Material Frayed 167 167
Material Puncture/Hole 160 160
Difficult to Insert 145 145
Insufficient Information 145 146
Retraction Problem 138 139
Use of Device Problem 129 131
Device Dislodged or Dislocated 126 126
Mechanical Problem 109 110
Incorrect, Inadequate or Imprecise Result or Readings 106 106
Device-Device Incompatibility 98 98
Device Damaged by Another Device 97 97
Packaging Problem 97 99
Air/Gas in Device 96 98
Stretched 92 92
Improper or Incorrect Procedure or Method 89 90
Unable to Obtain Readings 84 84
Appropriate Term/Code Not Available 77 79
Patient Device Interaction Problem 64 65
Positioning Problem 64 64
No Apparent Adverse Event 62 65
Device Damaged Prior to Use 61 61
Device Contamination with Chemical or Other Material 61 61
Failure to Deflate 55 55
Material Protrusion/Extrusion 55 55

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10825 10858
No Consequences Or Impact To Patient 1912 1912
Insufficient Information 887 890
Pericardial Effusion 520 523
Thrombosis/Thrombus 518 520
Foreign Body In Patient 509 515
Vascular Dissection 481 485
Low Blood Pressure/ Hypotension 341 341
Hemorrhage/Bleeding 327 394
Hematoma 276 339
Cardiac Perforation 269 270
No Known Impact Or Consequence To Patient 257 257
Intracranial Hemorrhage 257 322
Cardiac Tamponade 245 245
Perforation of Vessels 228 231
Stroke/CVA 189 190
Air Embolism 176 178
Obstruction/Occlusion 163 164
Device Embedded In Tissue or Plaque 149 151
Vasoconstriction 142 147
Embolism/Embolus 141 142
Non specific EKG/ECG Changes 137 139
Perforation 136 138
Ischemia Stroke 114 114
Cardiac Arrest 112 115
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 111 111
No Patient Involvement 93 93
Rupture 83 83
Thromboembolism 78 79
Pseudoaneurysm 76 77
Swelling/ Edema 73 74
Pain 73 73
Unspecified Nervous System Problem 72 72
Ischemia 70 71
Myocardial Infarction 67 67
Bradycardia 64 65
Arrhythmia 61 62
Stenosis 51 52
Unspecified Tissue Injury 48 48
Ruptured Aneurysm 45 45
Aneurysm 40 40
Death 40 41
Discomfort 40 40
Transient Ischemic Attack 36 37
No Code Available 34 34
High Blood Pressure/ Hypertension 34 34
Heart Block 34 38
Tachycardia 33 34
Needle Stick/Puncture 31 31
Headache 31 31

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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