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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 4
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 237
Detachment of device component 122
Kinked 70
Material separation 68
Aspiration issue 57
Tip breakage 49
No Known Device Problem 48
Deflation issue 44
Device displays error message 37
Material rupture 35
Fracture 31
Material deformation 31
Detachment of device or device component 30
Material fragmentation 27
Entrapment of device or device component 26
Device damaged prior to use 24
Device, or device fragments remain in patient 23
Difficult to remove 21
Shipping damage or problem 21
Balloon burst 20
Out-of-box failure 18
Leak 17
Component(s), broken 15
Balloon rupture 15
Stretched 14
Tears, rips, holes in device, device material 14
Failure to advance 13
Physical resistance 13
Burst 12
Decoupling 11
Difficult to advance 11
Material integrity issue 11
Difficult to insert 10
Hole in material 10
Unraveled material 10
Unsealed device packaging 9
Bent 9
Device packaging compromised 9
Device operates differently than expected 9
Tear, rip or hole in device packaging 9
Device handling issue 8
Collapse 8
Contamination during use 8
Retraction problem 8
Material puncture 5
Seal, defective 5
Crack 5
Slippage of device or device component 4
Torn material 4
No code available 4
Component missing 3
Malfunction 3
Defective item 3
Device or device fragments location unknown 3
Buckled material 3
Dislodged or dislocated 3
Shaft break 3
Defective component 3
Device inoperable 3
Other (for use when an appropriate device code cannot be identified) 3
Use of Device Issue 3
Inflation issue 3
Mechanical issue 2
Fluid leak 2
Foreign material 2
Decrease in suction 2
Blockage within device or device component 2
Balloon leak(s) 2
Improper or incorrect procedure or method 2
Size incorrect for patient 2
Unknown (for use when the device problem is not known) 2
Source, detachment from 2
Sterility 2
Sticking 2
Loss of power 2
Foreign material present in device 2
Device or device component damaged by another device 2
Material twisted 2
Mechanical jam 2
Split 2
Malposition of device 2
Folded 2
Cut in material 2
Wire(s), breakage of 2
Device Issue 2
Incomplete or missing packaging 1
Structural problem 1
Patient-device incompatibility 1
Positioning Issue 1
Device-device incompatibility 1
Material Distortion 1
Deployment issue 1
Incompatibility problem 1
Issue with displayed error message 1
Device Difficult to Setup or Prepare 1
Failure to prime 1
Peeled 1
Lead(s), breakage of 1
Material perforation 1
Stopcock valve, failure of 1
Total Device Problems 1416

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 1
Class II 2 0 3 1 1 1 1 0 2 0
Class III 1 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 Jun-25-2009
3 Arrow International Inc II Jun-24-2009
4 Boston Scientific Corporation I Apr-18-2016
5 Boston Scientific Corporation II Aug-13-2015
6 Ev3, Inc II Jul-11-2007
7 Invatec Llc II Jun-07-2013
8 LeMaitre Vascular, Inc. II Dec-04-2015
9 Possis Medical, Inc II Aug-10-2007
10 Possis Medical, Inc III Jun-21-2007
11 Spectranetics Corporation II Aug-09-2010
12 Vascular Solutions, Inc. II Aug-04-2011
13 Vascular Solutions, Inc. II Dec-17-2009

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