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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 9
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 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC IRELAND
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICRO THERAPEUTICS LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC., D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
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 1
SURMODICS. INC.
  SUBSTANTIALLY EQUIVALENT 1
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 2889
2021 3009 3011
2022 2644 2647
2023 3049 3112
2024 3192 3192
2025 2593 2593

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3355 3355
Adverse Event Without Identified Device or Use Problem 2849 2912
Break 1343 1345
Material Deformation 1140 1140
Detachment of Device or Device Component 943 944
Physical Resistance/Sticking 879 879
Deformation Due to Compressive Stress 785 785
Material Separation 766 766
Material Twisted/Bent 694 695
Leak/Splash 693 693
Difficult to Remove 597 597
Fracture 494 494
Fluid/Blood Leak 491 491
Material Integrity Problem 453 453
Difficult to Advance 410 410
Deflation Problem 374 374
Material Split, Cut or Torn 361 361
Unraveled Material 347 347
Crack 335 335
Failure to Advance 267 267
Inflation Problem 246 246
Entrapment of Device 220 220
Peeled/Delaminated 195 195
Burst Container or Vessel 194 194
Accessory Incompatible 169 169
Material Frayed 163 163
Obstruction of Flow 158 158
Material Puncture/Hole 155 155
Insufficient Information 141 141
Retraction Problem 135 135
Difficult to Insert 132 132
Use of Device Problem 124 124
Device Dislodged or Dislocated 122 122
Mechanical Problem 102 103
Packaging Problem 96 96
Incorrect, Inadequate or Imprecise Result or Readings 95 95
Device Damaged by Another Device 94 94
Device-Device Incompatibility 91 91
Stretched 87 87
Air/Gas in Device 86 86
Improper or Incorrect Procedure or Method 82 82
Appropriate Term/Code Not Available 71 71
Unable to Obtain Readings 69 69
Patient Device Interaction Problem 63 63
Device Damaged Prior to Use 61 61
No Apparent Adverse Event 58 58
Device Contamination with Chemical or Other Material 58 58
Positioning Problem 57 57
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 10347 10348
No Consequences Or Impact To Patient 1912 1912
Insufficient Information 847 848
Foreign Body In Patient 490 492
Thrombosis/Thrombus 483 483
Pericardial Effusion 477 477
Vascular Dissection 473 474
Hemorrhage/Bleeding 307 370
Low Blood Pressure/ Hypotension 305 305
Hematoma 270 333
No Known Impact Or Consequence To Patient 257 257
Intracranial Hemorrhage 256 319
Cardiac Perforation 243 243
Cardiac Tamponade 225 225
Perforation of Vessels 218 218
Stroke/CVA 184 184
Air Embolism 159 159
Obstruction/Occlusion 159 159
Device Embedded In Tissue or Plaque 146 146
Vasoconstriction 141 141
Embolism/Embolus 140 140
Perforation 128 128
Non specific EKG/ECG Changes 122 122
Ischemia Stroke 112 112
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 110 110
Cardiac Arrest 100 100
No Patient Involvement 93 93
Rupture 83 83
Thromboembolism 77 77
Pseudoaneurysm 74 74
Swelling/ Edema 74 74
Unspecified Nervous System Problem 74 74
Pain 68 68
Ischemia 67 67
Myocardial Infarction 62 62
Bradycardia 60 60
Arrhythmia 54 54
Stenosis 50 51
Ruptured Aneurysm 43 43
Unspecified Tissue Injury 42 42
Death 40 40
Transient Ischemic Attack 36 36
Aneurysm 36 36
No Code Available 34 34
Discomfort 34 34
High Blood Pressure/ Hypertension 34 34
Heart Block 32 32
Headache 31 31
Injury 29 29
Unspecified Infection 29 29

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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