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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, thrombus retriever
Regulation Description Percutaneous catheter.
Definition The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
Product CodeNRY
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 16
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 11

Device Problems
No Known Device Problem 396
Kinked 111
Out-of-box failure 104
Device damaged prior to use 90
Break 86
Fracture 57
Physical resistance 43
Difficult to remove 34
Aspiration issue 19
Stretched 18
Material separation 16
Device handling issue 16
Crack 12
Difficult to advance 12
Failure to advance 12
Device operates differently than expected 9
Material deformation 9
Sticking 8
Unraveled material 8
Retraction problem 8
Material integrity issue 7
Detachment of device or device component 7
Entrapment of device or device component 6
Difficult to insert 6
Bent 5
No Information 4
Detachment of device component 4
Leak 3
Material fragmentation 3
Mechanical jam 3
Flaked 3
Malfunction 2
Defective item 2
Fluid leak 2
Collapse 2
Air leak 2
Hole in material 2
No Pressure 2
Device, or device fragments remain in patient 2
Migration of device or device component 2
Patient-device incompatibility 2
Defective component 2
Improper or incorrect procedure or method 2
Suction issue 2
Component missing 2
Buckled material 2
Occlusion within device 2
Connection issue 1
Use of Device Issue 1
No flow 1
Therapeutic or diagnostic output failure 1
Not Applicable 1
Misconnection 1
Tear, rip or hole in device packaging 1
Material twisted 1
Human-Device Interface Issue 1
Knotted 1
Shaft break 1
Device packaging compromised 1
Device or device component damaged by another device 1
User used incorrect product for intended use 1
Device or device fragments location unknown 1
Mechanical issue 1
Cut in material 1
Noise, Audible 1
Difficult to position 1
Total Device Problems 1170

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 1 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 2 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Concentric Medical Inc II Dec-08-2014
2 Concentric Medical Inc II Sep-08-2014
3 Penumbra Inc. I Nov-24-2010

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