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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device system, endovascular graft, aortic aneurysm treatment
Product CodeMIH
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
53 47 41 39 34 12

Device Problems
Leak / Splash 6287
Adverse Event Without Identified Device or Use Problem 2709
Failure To Adhere Or Bond 1246
Migration or Expulsion of Device 929
Insufficient Information 867
Occlusion Within Device 749
Malposition of device 679
Hole In Material 666
Material Integrity Problem 527
Patient-Device Incompatibility 450
Material Puncture / Hole 429
Activation, Positioning or Separation Problem 378
Improper or Incorrect Procedure or Method 268
Unintended Movement 244
Detachment Of Device Component 231
Appropriate Term/Code Not Available 221
Loss of or Failure to Bond 212
Difficult to Remove 211
Use of Device Problem 206
Fluid Leak 203
Stretched 194
Break 177
Material Deformation 168
Off-Label Use 164
Detachment of Device or device Component 146
Difficult or Delayed Positioning 144
Failure to Advance 136
Fracture 130
Deformation Due to Compressive Stress 125
Partial Blockage 124
Migration 121
Obstruction of Flow 120
Positioning Failure 118
Kinked 117
Device Damaged by Another Device 115
Product Quality Problem 111
Material Separation 109
Device Dislodged or Dislocated 105
Difficult To Position 103
Collapse 85
Patient Device Interaction Problem 84
Device Operates Differently Than Expected 72
Difficult to Advance 71
Difficult to Insert 71
Complete Blockage 69
Inadequacy of Device Shape and/or Size 66
Folded 52
Activation Failure Including Expansion Failures 47
Misconnection 46
Positioning Problem 44
Torn Material 41
Stent 30
Inability to Irrigate 28
No Apparent Adverse Event 28
Separation Failure 24
Difficult or Delayed Activation 24
Material Twisted / Bent 24
Defective Device 23
Separation Problem 23
Microbial Contamination of Device 21
Failure to Unfold or Unwrap 20
Material Frayed 19
Device-Device Incompatibility 18
Compatibility Problem 18
Premature Activation 17
Retraction Problem 17
Material Rupture 17
Human-Device Interface Problem 17
Device Markings / Labelling Problem 16
Defective Component 16
Entrapment of Device 16
Material Split, Cut or Torn 16
Device Slipped 16
Material Invagination 16
Bent 16
Disconnection 14
Catheter 13
Mechanical Problem 12
Physical Resistance 12
Material Fragmentation 12
Device Expiration Issue 11
Mechanical Jam 10
Activation Problem 10
Infusion or Flow Problem 9
Burst Container or Vessel 9
Component or Accessory Incompatibility 8
Component Incompatible 7
Surgical Graft 7
Packaging Problem 7
Delamination 7
Physical Resistance / Sticking 6
Contamination During Use 6
Biocompatibility 6
Filling Problem 6
Device Contamination with Chemical or Other Material 6
Difficult to Open or Close 5
Component Missing 5
Valve 5
Other (for use when an appropriate device code cannot be identified) 5
Unintended Collision 4
Total Device Problems 21669

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Nov-05-2015
2 Cook Inc. II Jan-31-2020
3 Cook Inc. II Jun-19-2019
4 Cook Medical Incorporated I Aug-10-2017
5 Endologix I Oct-03-2018
6 Endologix II Jan-19-2017
7 Endologix II Jan-19-2017
8 Endologix II Jan-19-2017
9 Endologix II Jan-19-2017
10 Endologix II Jan-18-2017
11 Endologix II Jan-18-2017
12 Endologix II Jan-18-2017
13 Endologix, Inc. I Jun-11-2020
14 Medtronic Vascular, Inc. II Mar-15-2017
15 W L Gore & Associates, Inc. II May-20-2020
16 W L Gore & Associates, Inc. II Oct-25-2017
17 W. L. Gore & Associates Inc. II Feb-04-2020

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