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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 12

Device Problems
No Known Device Problem 502
Kinked 168
Out-of-box failure 163
Device damaged prior to use 159
Break 143
Fracture 86
Physical resistance 81
Difficult to remove 44
Stretched 33
Material separation 28
Aspiration issue 27
Device handling issue 27
Failure to advance 25
Device operates differently than expected 21
Material deformation 17
Retraction problem 16
Difficult to advance 15
Unraveled material 14
Crack 14
Entrapment of device or device component 11
Material integrity issue 10
Detachment of device or device component 9
Collapse 9
Sticking 9
Bent 8
Detachment of device component 7
Difficult to insert 7
Misconnection 7
Suction issue 5
Buckled material 4
Mechanical jam 4
Improper flow or infusion 4
No Information 4
Mechanical issue 4
Material fragmentation 3
Flaked 3
Occlusion within device 3
Pumping stopped 3
Leak 3
No Pressure 3
Patient-device incompatibility 3
Defective item 3
Defective component 2
Component missing 2
Malfunction 2
Obstruction within device 2
Material twisted 2
Foreign material present in device 2
Device or device component damaged by another device 2
Device packaging compromised 2
Shipping damage or problem 2
Improper or incorrect procedure or method 2
Device, or device fragments remain in patient 2
Device emits odor 2
Overheating of device or device component 2
Fluid leak 2
Decrease in suction 2
Hole in material 2
Air leak 2
Migration of device or device component 2
Knotted 2
Bleed back 1
Difficult to position 1
Decrease in pressure 1
User used incorrect product for intended use 1
Use of Device Issue 1
Shaft break 1
Human-Device Interface Issue 1
No flow 1
Therapeutic or diagnostic output failure 1
Not Applicable 1
Noise, Audible 1
Cut in material 1
Structural problem 1
Device contamination with blood or blood product 1
Tear, rip or hole in device packaging 1
Device or device fragments location unknown 1
Connection issue 1
Total Device Problems 1764

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 1 0 0 0 0 0 0 1
Class II 0 0 0 0 0 0 0 2 0 0 1
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 Jun-22-2017
4 Penumbra Inc. I Nov-24-2010
5 Stryker Neurovascular II Jul-29-2017

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