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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
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 4
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 446
Device displays error message 376
Break 326
Kinked 160
Detachment of device component 151
No Known Device Problem 117
Material separation 103
Physical resistance 87
Material deformation 71
Material rupture 70
Deflation issue 67
Entrapment of device or device component 51
Device damaged prior to use 51
Fracture 49
Tip breakage 49
Device operates differently than expected 46
Out-of-box failure 43
Failure to advance 40
Detachment of device or device component 40
Device handling issue 39
Leak 30
Material fragmentation 28
Burst 28
Difficult to remove 27
Device, or device fragments remain in patient 23
Shipping damage or problem 23
Stretched 22
Collapse 20
Balloon burst 20
Bent 19
Failure to prime 17
Hole in material 16
Difficult to insert 16
Balloon rupture 15
Component(s), broken 15
Difficult to advance 15
Tears, rips, holes in device, device material 14
Unraveled material 14
Device packaging compromised 13
Material integrity issue 12
Decoupling 11
Contamination during use 10
Fluid leak 10
Retraction problem 10
Unsealed device packaging 9
Crack 9
Tear, rip or hole in device packaging 9
Slippage of device or device component 8
Buckled material 7
Torn material 7
No code available 6
Dislodged or dislocated 6
Defective item 6
Seal, defective 5
Material twisted 5
Mechanical jam 5
Material puncture 5
Device inoperable 4
Device clogged 4
Material frayed 4
Device or device fragments location unknown 4
Device or device component damaged by another device 4
Folded 3
Split 3
Malfunction 3
Defective component 3
Foreign material present in device 3
Improper flow or infusion 3
Component missing 3
Inflation issue 3
Use of Device Issue 3
Other (for use when an appropriate device code cannot be identified) 3
Size incorrect for patient 3
Sticking 3
Device Difficult to Setup or Prepare 3
Shaft break 3
Occlusion within device 2
Overheating of device or device component 2
Loss of power 2
Source, detachment from 2
Sterility 2
Unknown (for use when the device problem is not known) 2
Improper or incorrect procedure or method 2
Mechanical issue 2
Foreign material 2
Blockage within device or device component 2
Balloon leak(s) 2
Decrease in suction 2
Disconnection 2
Incompatibility problem 2
Wire(s), breakage of 2
Device Issue 2
Cut in material 2
Structural problem 2
Malposition of device 2
Component or accessory incompatibility 2
Connection issue 2
Delamination 1
Deployment issue 1
Patient-device incompatibility 1
Total Device Problems 3004

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 1
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 Edwards Lifesciences, LLC II Aug-26-2017
8 Ev3, Inc II Jul-11-2007
9 Invatec Llc II Jun-07-2013
10 LeMaitre Vascular, Inc. II Dec-04-2015
11 Possis Medical, Inc II Aug-10-2007
12 Possis Medical, Inc III Jun-21-2007
13 Spectranetics Corporation II Aug-09-2010
14 Vascular Solutions, Inc. II Aug-04-2011
15 Vascular Solutions, Inc. II Dec-17-2009

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