Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device wire, guide, catheter
Product CodeDQX
Regulation Number 870.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 12
ABBOTT VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 6
ABBOTT VASCULAR-CARDIAC THERAPIES
  SUBSTANTIALLY EQUIVALENT 3
ACME-MONACO CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 27
ASAHI INTECC CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASHITAKA FACTORY OF TERUMO COPORATION
  SUBSTANTIALLY EQUIVALENT 1
ASHITAKA FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERICS NLE
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
BOSTON SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 1
BRIDGEPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
BRIVANT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BRIVANT LIMITED (LAKE REGION MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
BRIVANT, LTD.
  SUBSTANTIALLY EQUIVALENT 6
CARDIO FLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOSOLUTIONS INC
  SUBSTANTIALLY EQUIVALENT 1
CENTURION MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
COEUR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONCERT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 12
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 4
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
DISTAL ACCESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
EMBRACE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
FILMEC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
FILMECC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
FILMECC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
FILMECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FLAT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FMD CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUIDEPATH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
LAKE REGION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAKE REGION MFG., INC.
  SUBSTANTIALLY EQUIVALENT 1
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 1
MEDIVALVE LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC CORE VALVE, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC COREVALVE, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 14
MICRO THERAPEUTICS, INC D/B/A: EV3 INC
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRUS ENDOVASCULAR CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NANO4IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 2
NAVIS MEDICAL,INC
  SUBSTANTIALLY EQUIVALENT 1
NEEDLETECH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEO METRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOMETRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPSENS
  SUBSTANTIALLY EQUIVALENT 1
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 2
OPSENS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
PHENOX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA CARDIO ACCESS LLC
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 3
SEVEN SONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHEPHERD SCIENTIFIC INC
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
  SUBSTANTIALLY EQUIVALENT 1
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUREFIRE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU INNOMED MEDICAL DEVICE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
TATARA VASCULAR, LLC.
  SUBSTANTIALLY EQUIVALENT 1
TECHDEVICE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TEXAS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VADISWIRE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 7
VESATEK, LLC
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1316 1316
2015 1322 1322
2016 1463 1463
2017 1523 1523
2018 1736 1736
2019 1677 1677
2020 1536 2024
2021 1712 3054
2022 1647 1647
2023 2069 2069
2024 541 541

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 2250 2250
Break 1907 1907
Material Separation 1850 2826
Detachment Of Device Component 1565 1565
Fracture 1450 1450
Peeled/Delaminated 1398 1398
Detachment of Device or Device Component 1285 1285
Adverse Event Without Identified Device or Use Problem 1238 1360
Entrapment of Device 1052 2028
Difficult to Advance 932 932
Failure to Advance 749 749
Stretched 638 638
Material Deformation 528 528
Unraveled Material 509 509
Improper or Incorrect Procedure or Method 460 460
Material Integrity Problem 443 443
Deformation Due to Compressive Stress 414 414
Difficult To Position 350 350
Physical Resistance/Sticking 322 322
Insufficient Information 294 294
Material Split, Cut or Torn 276 276
Kinked 233 233
Device Damaged by Another Device 197 197
Material Fragmentation 186 186
Physical Resistance 157 157
Material Twisted/Bent 156 156
Flaked 152 152
Positioning Problem 151 151
Device Operates Differently Than Expected 149 149
Material Frayed 147 147
Product Quality Problem 124 124
Material Protrusion/Extrusion 106 106
Off-Label Use 92 92
Device Damaged Prior to Use 85 85
Use of Device Problem 81 81
Bent 80 80
Difficult to Insert 78 78
Fluid/Blood Leak 69 69
Device Contamination with Chemical or Other Material 62 62
Contamination /Decontamination Problem 59 59
Device Dislodged or Dislocated 57 57
Material Too Soft/Flexible 55 55
Leak/Splash 55 55
Defective Device 50 50
Unsealed Device Packaging 47 47
Occlusion Within Device 46 46
Delamination 46 46
Activation, Positioning or Separation Problem 45 45
Torn Material 42 42
Physical Property Issue 42 42
Appropriate Term/Code Not Available 40 40
Device Contaminated During Manufacture or Shipping 36 36
Sticking 36 36
Material Too Rigid or Stiff 31 31
Uncoiled 30 30
Device Markings/Labelling Problem 30 30
Device Misassembled During Manufacturing /Shipping 28 28
Mechanical Problem 28 28
Crack 28 28
Migration or Expulsion of Device 26 26
Patient Device Interaction Problem 26 26
Retraction Problem 25 25
Obstruction of Flow 24 24
Mechanical Jam 24 24
Device-Device Incompatibility 24 24
Difficult or Delayed Positioning 23 23
Device Or Device Fragments Location Unknown 21 21
Malposition of Device 21 21
Material Puncture/Hole 20 20
Delivered as Unsterile Product 20 20
Communication or Transmission Problem 19 19
Split 19 19
Material Perforation 18 18
Tear, Rip or Hole in Device Packaging 17 17
Device Displays Incorrect Message 17 17
Component Missing 15 15
No Apparent Adverse Event 15 15
Sharp Edges 15 137
Connection Problem 14 14
Material Distortion 14 14
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Unable to Obtain Readings 13 13
Collapse 13 13
Packaging Problem 13 13
Device Handling Problem 12 12
Patient-Device Incompatibility 12 12
Partial Blockage 11 11
Pressure Problem 11 11
Scratched Material 11 11
Output Problem 10 10
Structural Problem 10 10
Cut In Material 9 9
Separation Failure 9 9
Defective Component 9 9
Other (for use when an appropriate device code cannot be identified) 9 9
Accessory Incompatible 9 9
Contamination 9 9
Disconnection 9 9
Device Difficult to Setup or Prepare 9 9
Material Torqued 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4992 4992
No Clinical Signs, Symptoms or Conditions 3654 4752
Foreign Body In Patient 1649 1649
Device Embedded In Tissue or Plaque 1496 1496
No Known Impact Or Consequence To Patient 1302 1790
No Patient Involvement 545 545
Vascular Dissection 516 638
Insufficient Information 384 384
Perforation of Vessels 384 506
Perforation 311 311
Vessel Or Plaque, Device Embedded In 296 296
Death 279 279
Pericardial Effusion 212 212
Cardiac Tamponade 203 203
No Code Available 198 198
Cardiac Perforation 190 190
Low Blood Pressure/ Hypotension 190 190
No Information 175 175
Intimal Dissection 131 131
Hemorrhage/Bleeding 121 121
Myocardial Infarction 111 111
Hematoma 76 76
Stroke/CVA 74 74
Obstruction/Occlusion 70 70
Cardiac Arrest 66 66
Pain 62 62
Patient Problem/Medical Problem 55 55
Blood Loss 54 54
Occlusion 54 54
Thrombosis 51 51
Embolism 50 50
Vasoconstriction 49 49
Rupture 42 42
Hemoptysis 39 39
Intracranial Hemorrhage 34 34
Embolism/Embolus 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Thrombosis/Thrombus 30 30
Chest Pain 29 29
Injury 28 28
Bradycardia 27 27
Hemorrhage, Subarachnoid 26 26
Headache 26 26
Laceration(s) 25 25
Arrhythmia 25 25
Angina 24 24
Thrombus 24 24
Tissue Damage 22 22
Cardiogenic Shock 20 20
Calcium Deposits/Calcification 20 20
Unspecified Infection 19 19
Ischemia 18 18
Stenosis 18 18
High Blood Pressure/ Hypertension 17 17
Unspecified Tissue Injury 17 17
Hemorrhage, Cerebral 16 16
Aneurysm 16 16
Tachycardia 16 16
Extravasation 15 15
Embolus 14 14
Ventricular Fibrillation 14 14
Discomfort 13 13
Inflammation 13 13
Aortic Dissection 13 13
Pseudoaneurysm 12 12
Foreign Body Embolism 12 12
Non specific EKG/ECG Changes 12 12
Atrial Fibrillation 12 12
Needle Stick/Puncture 11 11
Respiratory Failure 10 10
Complete Heart Block 10 10
Failure of Implant 9 9
Dyspnea 9 9
Nonresorbable materials, unretrieved in body 9 9
Foreign body, removal of 9 9
Internal Organ Perforation 9 9
Transient Ischemic Attack 9 9
ST Segment Elevation 9 9
Neurological Deficit/Dysfunction 8 8
Paralysis 8 8
Pleural Effusion 8 8
Ventricular Tachycardia 8 8
Great Vessel Perforation 8 8
Cardiopulmonary Arrest 8 8
Infarction, Cerebral 8 8
Diminished Pulse Pressure 8 8
Swelling/ Edema 7 7
Bone Fracture(s) 7 7
Mitral Regurgitation 7 7
Swelling 7 7
Sepsis 7 7
Pneumothorax 6 6
Fistula 6 6
Air Embolism 6 6
Vascular System (Circulation), Impaired 6 6
Not Applicable 6 6
Mitral Valve Insufficiency/ Regurgitation 5 5
Loss Of Pulse 5 5
Surgical procedure, additional 5 5
Atrial Perforation 5 5

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. I Mar-21-2024
2 Abbott Vascular II Jul-12-2011
3 Abbott Vascular, Inc. II Dec-20-2013
4 Anewmed Corporation II Oct-31-2019
5 Argon Medical Devices, Inc I May-07-2020
6 Argon Medical Devices, Inc II May-26-2009
7 Arrow International Inc II Jan-23-2020
8 Arrow International Inc II May-30-2018
9 Arrow International Inc II Apr-10-2018
10 Arrow International Inc II Apr-02-2018
11 Arrow International Inc II Jun-12-2017
12 Arrow International Inc II Sep-07-2016
13 Arrow International Inc II Jul-12-2016
14 Arrow International Inc II Feb-17-2011
15 Arrow International Inc II Sep-25-2010
16 Baylis Medical Corp * II Dec-01-2015
17 Baylis Medical Corp * II Apr-13-2015
18 Boston Scientific Corporation II Feb-20-2019
19 Boston Scientific Corporation II Apr-12-2016
20 Boston Scientific Corporation II Aug-23-2011
21 Boston Scientific Corporation II Jan-07-2011
22 Boston Scientific Corporation II Jul-22-2010
23 Boston Scientific Corporation II Jun-04-2010
24 Boston Scientific Corporation II Jun-24-2009
25 Cook Inc. I Nov-03-2020
26 Cook Inc. II Mar-09-2018
27 Cook Inc. I Aug-25-2016
28 Cook Incorporated II Sep-28-2022
29 Cook Incorporated II Sep-09-2022
30 Cordis Corporation II Jan-13-2010
31 EXP Pharmaceutical Services Corp II Jul-24-2015
32 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-28-2013
33 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-28-2013
34 Medtronic Vascular I Nov-15-2013
35 Merit Medical Systems, Inc. II Jun-26-2015
36 Merit Medical Systems, Inc. II Apr-22-2014
37 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
38 Nipro Medical Corporation II Oct-25-2012
39 Nitinol Devices and Components, Inc. I Jun-25-2014
40 SentreHeart Inc I Nov-09-2016
41 St. Jude Medical II Sep-18-2009
42 St. Jude Medical II Aug-17-2009
43 Stryker Neurovascular II Oct-29-2019
44 Terumo Medical Corporation II Jul-20-2011
45 Volcano Corporation II Jun-25-2015
46 Volcano Corporation II Feb-01-2012
-
-