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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 8

Device Problems
No Known Device Problem 261
Out-of-box failure 51
Break 49
Kinked 45
Device damaged prior to use 39
Fracture 35
Difficult to remove 25
Physical resistance 15
Stretched 11
Difficult to advance 8
Material separation 8
Sticking 8
Aspiration issue 8
Crack 7
Difficult to insert 6
Retraction problem 6
Unraveled material 5
Failure to advance 5
Entrapment of device or device component 5
Material deformation 5
Detachment of device component 4
Detachment of device or device component 4
No Information 4
Material integrity issue 4
Bent 3
Flaked 3
Device handling issue 3
Material fragmentation 2
Hole in material 2
Malfunction 2
Device operates differently than expected 2
Migration of device or device component 2
Device, or device fragments remain in patient 2
Improper or incorrect procedure or method 2
Defective component 2
Occlusion within device 2
Suction issue 2
Component missing 2
Buckled material 2
No flow 1
Therapeutic or diagnostic output failure 1
Use of Device Issue 1
Connection issue 1
Tear, rip or hole in device packaging 1
Human-Device Interface Issue 1
Material twisted 1
Noise, Audible 1
Fluid leak 1
Difficult to position 1
Collapse 1
Cut in material 1
Defective item 1
Device or device fragments location unknown 1
Air leak 1
Device or device component damaged by another device 1
Device packaging compromised 1
Knotted 1
Shaft break 1
Total Device Problems 670

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