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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 2
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.
  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
Break 270
Aspiration issue 235
Device displays error message 199
Detachment of device component 129
Kinked 99
Material separation 79
No Known Device Problem 71
Deflation issue 53
Tip breakage 49
Material deformation 44
Material rupture 41
Entrapment of device or device component 38
Fracture 37
Physical resistance 36
Device damaged prior to use 35
Detachment of device or device component 31
Material fragmentation 27
Out-of-box failure 26
Device, or device fragments remain in patient 23
Difficult to remove 23
Device operates differently than expected 22
Shipping damage or problem 21
Leak 20
Balloon burst 20
Failure to advance 19
Device handling issue 16
Balloon rupture 15
Component(s), broken 15
Stretched 15
Tears, rips, holes in device, device material 14
Difficult to advance 13
Difficult to insert 12
Hole in material 12
Burst 12
Collapse 11
Bent 11
Decoupling 11
Material integrity issue 11
Device packaging compromised 10
Unraveled material 10
Unsealed device packaging 9
Contamination during use 9
Tear, rip or hole in device packaging 9
Retraction problem 8
Failure to prime 7
Material puncture 5
Seal, defective 5
Crack 5
Torn material 5
No code available 5
Material twisted 4
Device inoperable 4
Slippage of device or device component 4
Shaft break 3
Other (for use when an appropriate device code cannot be identified) 3
Defective component 3
Use of Device Issue 3
Size incorrect for patient 3
Inflation issue 3
Fluid leak 3
Mechanical jam 3
Malfunction 3
Component missing 3
Dislodged or dislocated 3
Defective item 3
Device or device fragments location unknown 3
Buckled material 3
Device or device component damaged by another device 2
Foreign material present in device 2
Incompatibility problem 2
Cut in material 2
Structural problem 2
Split 2
Wire(s), breakage of 2
Device Issue 2
Malposition of device 2
Folded 2
Foreign material 2
Material frayed 2
Mechanical issue 2
Decrease in suction 2
Blockage within device or device component 2
Balloon leak(s) 2
Improper or incorrect procedure or method 2
Unknown (for use when the device problem is not known) 2
Source, detachment from 2
Sterility 2
Sticking 2
Loss of power 2
Occlusion within device 2
Overheating of device or device component 1
Peeled 1
Device Difficult to Setup or Prepare 1
Material perforation 1
Stopcock valve, failure of 1
Suction issue 1
Fitting problem 1
Telemetry discrepancy 1
Device clogged 1
Deflation due to damage from surgical instrument 1
Total Device Problems 2012

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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