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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, hemostasis, vascular
Product CodeMGB
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
18 20 34 22 23 16 12 26 28 18

Device Problems
Device operates differently than expected 1708
Difficult to remove 1312
Failure to deploy 1303
Couple, failure to 1164
Unknown (for use when the device problem is not known) 785
Source, detachment from 441
Improper or incorrect procedure or method 434
Detachment of device component 418
Mislocation 321
Use of Device Issue 319
Difficult to deploy 279
Retraction problem 259
No Known Device Problem 257
Break 210
Other (for use when an appropriate device code cannot be identified) 169
Method, improper/incorrect 142
Difficult to insert 118
Resistance, loss of 103
Difficult to position 102
Blockage within device or device component 102
Bent 96
Collapse 91
Physical resistance 79
Material rupture 76
Deployment issue 57
Kinked 42
Loose 42
No Information 37
Failure to advance 32
Leak 30
Premature deployment 26
Component missing 24
Failure to cut 19
Therapy delivered to incorrect body area 18
Device, removal of (non-implant) 17
Failure to separate 17
Migration of device or device component 15
Device Issue 13
Inaccurate delivery 12
Difficult to advance 12
Torn material 11
Device damaged prior to use 8
Stretched 8
Foreign material present in device 7
Dislodged or dislocated 6
Detachment of device or device component 6
Sticking 6
Device expiration issue 6
Packaging issue 5
Mechanical jam 5
Malposition of device 4
Material deformation 4
Misplacement 4
Deflation issue 4
Tears, rips, holes in device, device material 4
Twisting 4
Material separation 4
Inadequate training 3
Occlusion within device 3
Loose or intermittent connection 3
Defective item 3
Malfunction 3
No code available 3
Material twisted 2
Unintended movement 2
Seal, defective 2
Failure to deliver 2
Patient-device incompatibility 2
Device or device component damaged by another device 2
Fluid leak 2
Fracture 2
Unsealed device packaging 2
Delivered as unsterile product 2
Misassembled 2
Entrapment of device or device component 2
Dislodged 2
Burst 2
Noise 2
Material perforation 2
Tip breakage 2
Device, or device fragments remain in patient 2
Slippage of device or device component 2
Seal, incorrect 2
Rejection 2
Device remains implanted 1
Incorrect or inadequate result 1
Decrease in pressure 1
Material puncture 1
Reverse osmosis 1
Shaft, split 1
Shelf life exceeded 1
Failure to select signal 1
Size incorrect for patient 1
Suture line separation 1
Syringe, defective 1
Device inoperable 1
Coiled 1
Component(s), broken 1
Alarm, no lead 1
Failure to Adhere or Bond 1
Total Device Problems 10873

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 1 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Jul-06-2009
2 Cordis Corporation II Jan-25-2013
3 EXP Pharmaceutical Services Corp II Jul-24-2015

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