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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, embolectomy
Regulation Description Embolectomy catheter.
Product CodeDXE
Regulation Number 870.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 3
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K011056  ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE O ...
  2.  K982141  ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL ...
ARTEGRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 3
FOXHOLLOW TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
IDEV TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 2
KERBEROS PROXIMAL SOLUTIONS, INC.
  SE - WITH LIMITATIONS 2
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUCAS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
LUMEN
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 7
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROVENA
  SUBSTANTIALLY EQUIVALENT 2
PENUMBRA, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 5
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 20
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 5
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 11
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Aspiration issue 427
Device displays error message 360
Break 316
Detachment of device component 139
Kinked 136
No Known Device Problem 105
Material separation 99
Physical resistance 70
Material deformation 61
Deflation issue 60
Material rupture 58
Tip breakage 49
Device damaged prior to use 45
Entrapment of device or device component 45
Fracture 43
Device operates differently than expected 40
Out-of-box failure 38
Detachment of device or device component 35
Device handling issue 30
Burst 28
Material fragmentation 27
Leak 27
Difficult to remove 27
Failure to advance 27
Device, or device fragments remain in patient 23
Shipping damage or problem 23
Stretched 20
Balloon burst 20
Bent 16
Collapse 16
Component(s), broken 15
Hole in material 15
Balloon rupture 15
Tears, rips, holes in device, device material 14
Unraveled material 14
Difficult to advance 14
Device packaging compromised 13
Difficult to insert 13
Failure to prime 12
Material integrity issue 12
Decoupling 11
Contamination during use 10
Unsealed device packaging 9
Tear, rip or hole in device packaging 9
Retraction problem 8
Crack 7
Fluid leak 7
Buckled material 6
Torn material 6
No code available 6
Mechanical jam 5
Defective item 5
Dislodged or dislocated 5
Seal, defective 5
Material puncture 5
Slippage of device or device component 5
Device inoperable 4
Device clogged 4
Device or device component damaged by another device 4
Material twisted 4
Component missing 3
Device or device fragments location unknown 3
Malfunction 3
Split 3
Inflation issue 3
Use of Device Issue 3
Defective component 3
Other (for use when an appropriate device code cannot be identified) 3
Size incorrect for patient 3
Shaft break 3
Loss of power 2
Device Difficult to Setup or Prepare 2
Occlusion within device 2
Unknown (for use when the device problem is not known) 2
Improper or incorrect procedure or method 2
Source, detachment from 2
Sterility 2
Sticking 2
Mechanical issue 2
Foreign material 2
Material frayed 2
Blockage within device or device component 2
Balloon leak(s) 2
Decrease in suction 2
Disconnection 2
Wire(s), breakage of 2
Device Issue 2
Malposition of device 2
Folded 2
Cut in material 2
Structural problem 2
Connection issue 2
Foreign material present in device 2
Incompatibility problem 2
Issue with displayed error message 1
Device-device incompatibility 1
Delamination 1
Deployment issue 1
Device markings issue 1
Disinfection or Sterilization Issue at User Location 1
Total Device Problems 2756

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 1 0
Class II 2 0 3 1 1 1 1 0 2 1 0
Class III 1 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Sep-25-2012
2 Arrow International Inc II Sep-30-2016
3 Arrow International Inc II Jun-25-2009
4 Arrow International Inc II Jun-24-2009
5 Boston Scientific Corporation I Apr-18-2016
6 Boston Scientific Corporation II Aug-13-2015
7 Ev3, Inc II Jul-11-2007
8 Invatec Llc II Jun-07-2013
9 LeMaitre Vascular, Inc. II Dec-04-2015
10 Possis Medical, Inc II Aug-10-2007
11 Possis Medical, Inc III Jun-21-2007
12 Spectranetics Corporation II Aug-09-2010
13 Vascular Solutions, Inc. II Aug-04-2011
14 Vascular Solutions, Inc. II Dec-17-2009

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