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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 253
Detachment of device component 126
Aspiration issue 95
Kinked 81
Material separation 76
Device displays error message 72
No Known Device Problem 56
Tip breakage 49
Deflation issue 49
Material deformation 39
Material rupture 38
Fracture 35
Entrapment of device or device component 30
Detachment of device or device component 30
Material fragmentation 27
Device damaged prior to use 27
Physical resistance 24
Device, or device fragments remain in patient 23
Difficult to remove 22
Shipping damage or problem 21
Out-of-box failure 21
Balloon burst 20
Failure to advance 18
Leak 17
Component(s), broken 15
Balloon rupture 15
Stretched 14
Tears, rips, holes in device, device material 14
Burst 12
Difficult to advance 12
Device operates differently than expected 11
Material integrity issue 11
Decoupling 11
Hole in material 11
Difficult to insert 10
Collapse 10
Bent 10
Unraveled material 10
Device packaging compromised 10
Device handling issue 10
Tear, rip or hole in device packaging 9
Unsealed device packaging 9
Retraction problem 8
Contamination during use 8
Crack 5
Material puncture 5
Seal, defective 5
Slippage of device or device component 4
Torn material 4
No code available 4
Malfunction 3
Defective item 3
Device or device fragments location unknown 3
Component missing 3
Mechanical jam 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
Material frayed 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
Split 2
Malposition of device 2
Folded 2
Cut in material 2
Structural problem 2
Wire(s), breakage of 2
Device Issue 2
Incomplete or missing packaging 1
Patient-device incompatibility 1
Device-device incompatibility 1
Material Distortion 1
Deployment issue 1
Incompatibility problem 1
Issue with displayed error message 1
Positioning Issue 1
Device Difficult to Setup or Prepare 1
Failure to prime 1
Peeled 1
Lead(s), breakage of 1
Material perforation 1
Total Device Problems 1596

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 1
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 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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