• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 412
Kinked 127
Out-of-box failure 121
Device damaged prior to use 110
Break 101
Fracture 61
Physical resistance 50
Difficult to remove 36
Stretched 21
Aspiration issue 19
Material separation 18
Device handling issue 17
Device operates differently than expected 13
Difficult to advance 12
Failure to advance 12
Crack 12
Material deformation 10
Unraveled material 9
Retraction problem 8
Detachment of device or device component 8
Sticking 8
Material integrity issue 7
Entrapment of device or device component 7
Difficult to insert 6
Collapse 5
Bent 5
Detachment of device component 4
No Information 4
Mechanical jam 3
Buckled material 3
Defective item 3
Flaked 3
Material fragmentation 3
Leak 3
Mechanical issue 2
Migration of device or device component 2
Hole in material 2
Fluid leak 2
Air leak 2
Device, or device fragments remain in patient 2
Occlusion within device 2
Improper or incorrect procedure or method 2
Defective component 2
Component missing 2
Malfunction 2
Patient-device incompatibility 2
Device or device component damaged by another device 2
No Pressure 2
Therapeutic or diagnostic output failure 1
Not Applicable 1
No flow 1
Noise, Audible 1
Device packaging compromised 1
Material twisted 1
Human-Device Interface Issue 1
Cut in material 1
Structural problem 1
Device or device fragments location unknown 1
Connection issue 1
Tear, rip or hole in device packaging 1
Suction issue 1
Use of Device Issue 1
Difficult to position 1
User used incorrect product for intended use 1
Shaft break 1
Knotted 1
Misconnection 1
Total Device Problems 1288

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

-
-