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 introducer, catheter
Product CodeDYB
Regulation Number 870.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
ABIOMED INC.
  SUBSTANTIALLY EQUIVALENT 4
ACUTUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 3
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 4
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 3
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOCARDIA
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
C.R.BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 2
CIRCA SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTRACT MEDICAL INTERNATIONAL GMBH
  SUBSTANTIALLY EQUIVALENT 3
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
CURATIA MEDICAL CO.
  SUBSTANTIALLY EQUIVALENT 1
DIB ULTRANAV MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EAST END MEDICAL I LLC
  SUBSTANTIALLY EQUIVALENT 1
EAST END MEDICAL I, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
INNEUROCO INC.
  SUBSTANTIALLY EQUIVALENT 1
KEYSTONE HEART, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PULNOVO MEDICAL (WUXI) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SONOSTIK, LLC
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TALON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIZARAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2465 2465
2021 2835 3045
2022 4084 8472
2023 3784 7892
2024 3932 7931

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2725 2750
Adverse Event Without Identified Device or Use Problem 2291 8876
Fluid/Blood Leak 2214 2214
Detachment of Device or Device Component 1126 1126
Break 973 1183
Material Deformation 873 873
Gas/Air Leak 812 812
Material Split, Cut or Torn 712 712
Backflow 494 494
Physical Resistance/Sticking 464 464
Device-Device Incompatibility 438 438
Patient Device Interaction Problem 438 438
Difficult to Insert 419 419
Leak/Splash 411 482
Material Puncture/Hole 405 405
Peeled/Delaminated 363 363
Difficult to Advance 345 345
Unraveled Material 330 330
Obstruction of Flow 306 306
Failure to Advance 281 281
Difficult to Remove 269 278
Insufficient Information 258 6178
Fracture 218 218
Material Twisted/Bent 203 203
Material Integrity Problem 197 197
Material Frayed 190 190
Flaked 190 190
Contamination /Decontamination Problem 161 161
Appropriate Term/Code Not Available 154 154
Use of Device Problem 153 153
Patient-Device Incompatibility 137 137
Material Too Rigid or Stiff 135 135
Defective Component 120 135
Device Contamination with Chemical or Other Material 120 120
Deformation Due to Compressive Stress 101 101
Entrapment of Device 83 83
Improper or Incorrect Procedure or Method 81 81
Activation, Positioning or Separation Problem 76 76
Separation Problem 59 59
Defective Device 59 59
Stretched 58 58
Mechanical Problem 58 58
Device Contaminated During Manufacture or Shipping 54 54
Component Misassembled 53 53
Crack 52 52
Air/Gas in Device 50 50
Material Protrusion/Extrusion 50 50
Manufacturing, Packaging or Shipping Problem 49 49
Positioning Problem 48 48
Partial Blockage 45 45

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10398 10398
No Consequences Or Impact To Patient 1343 1492
Vascular Dissection 846 1138
Hemorrhage/Bleeding 651 1972
Insufficient Information 609 651
Foreign Body In Patient 511 511
Cardiac Perforation 387 387
Hematoma 310 1424
Perforation of Vessels 307 307
Unspecified Vascular Problem 285 4320
Pericardial Effusion 265 265
Cardiac Tamponade 243 243
Low Blood Pressure/ Hypotension 191 191
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 150 5166
Blood Loss 140 145
No Known Impact Or Consequence To Patient 134 134
Air Embolism 131 131
Pseudoaneurysm 126 126
Thrombosis/Thrombus 115 115
Retroperitoneal Hemorrhage 107 856
Obstruction/Occlusion 99 99
No Patient Involvement 94 100
Stroke/CVA 84 84
Perforation 80 80
Cardiac Arrest 80 80
No Code Available 79 79
Device Embedded In Tissue or Plaque 75 75
Aneurysm 71 71
Pain 66 66
Bacterial Infection 57 81
Unspecified Infection 55 73
Rupture 52 52
Arrhythmia 48 48
Fistula 46 46
Embolism/Embolus 46 46
Death 44 44
Unspecified Tissue Injury 40 40
Thromboembolism 39 39
Great Vessel Perforation 35 35
Heart Block 34 34
Foreign Body Embolism 30 30
Stenosis 26 26
Cramp(s) /Muscle Spasm(s) 24 24
Tachycardia 22 22
Ischemic Heart Disease 22 22
No Information 22 22
Bradycardia 20 20
Pulmonary Embolism 19 19
Bruise/Contusion 19 49
Transient Ischemic Attack 19 19

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Dec-27-2021
2 Abbott Medical II Jan-08-2020
3 Abbott Medical II Jan-07-2020
4 Abiomed, Inc. II Jan-05-2024
5 Abiomed, Inc. II Jul-11-2023
6 Acutus Medical Inc II Apr-23-2020
7 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-21-2021
8 Argon Medical Devices, Inc II Sep-21-2021
9 Argon Medical Devices, Inc II Feb-05-2021
10 Arrow International Inc II Feb-14-2020
11 Baylis Medical Company Inc. II May-21-2020
12 Biosense Webster, Inc. II Sep-02-2022
13 Biosense Webster, Inc. II Mar-22-2021
14 Biosense Webster, Inc. II Mar-13-2024
15 Biosense Webster, Inc. II Apr-01-2023
16 Boston Scientific Corporation II Mar-28-2024
17 Cook Inc. II Dec-16-2021
18 Cook Inc. II Oct-29-2021
19 Cook Inc. I Dec-23-2020
20 Cook Incorporated II Oct-09-2024
21 Cook Incorporated II Apr-12-2024
22 Creganna Medical Devices II Jul-28-2023
23 Datascope Corp. II Jul-21-2023
24 Freudenberg Medical, Llc II Apr-28-2022
25 Galt Medical Corporation II Jun-15-2023
26 Medtronic Vascular Galway DBA Medtronic Ireland I May-27-2020
27 Merit Medical Systems, Inc. II Aug-12-2024
28 Merit Medical Systems, Inc. II Jun-27-2024
29 Merit Medical Systems, Inc. II May-20-2024
30 Merit Medical Systems, Inc. II May-10-2023
31 Merit Medical Systems, Inc. II Aug-12-2021
32 Merit Medical Systems, Inc. II Aug-10-2021
33 Merit Medical Systems, Inc. II May-11-2020
34 Oscor Inc. II Feb-17-2022
35 Oscor, Inc. II Apr-01-2021
36 St. Jude Medical II Jul-12-2024
37 W. L. Gore & Associates Inc. II May-11-2020
-
-