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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 2
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 210
Detachment of device component 117
Material separation 55
Kinked 54
Tip breakage 49
Deflation issue 42
No Known Device Problem 30
Detachment of device or device component 29
Material rupture 28
Material fragmentation 27
Fracture 26
Device, or device fragments remain in patient 23
Difficult to remove 21
Shipping damage or problem 21
Balloon burst 20
Material deformation 19
Aspiration issue 17
Entrapment of device or device component 17
Balloon rupture 15
Component(s), broken 15
Device damaged prior to use 15
Tears, rips, holes in device, device material 14
Leak 13
Burst 12
Decoupling 11
Failure to advance 11
Device displays error message 10
Difficult to insert 10
Unraveled material 10
Tear, rip or hole in device packaging 9
Bent 9
Hole in material 9
Unsealed device packaging 8
Out-of-box failure 8
Stretched 8
Device packaging compromised 8
Difficult to advance 7
Physical resistance 7
Retraction problem 7
Contamination during use 7
Device operates differently than expected 6
Crack 5
Seal, defective 5
Material puncture 4
Slippage of device or device component 4
No code available 4
Component missing 3
Dislodged or dislocated 3
Defective item 3
Device or device fragments location unknown 3
Shaft break 3
Device inoperable 3
Malfunction 3
Defective component 3
Other (for use when an appropriate device code cannot be identified) 3
Inflation issue 3
Foreign material 2
Loss of power 2
Blockage within device or device component 2
Balloon leak(s) 2
Unknown (for use when the device problem is not known) 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
Cut in material 2
Wire(s), breakage of 2
Device Issue 2
Source, detachment from 2
Sterility 2
Sticking 2
Split 2
Malposition of device 2
Foreign material present in device 2
Device or device component damaged by another device 2
Buckled material 2
Torn material 2
Material twisted 2
Mechanical jam 1
Positioning Issue 1
Deployment issue 1
Incompatibility problem 1
Folded 1
Patient-device incompatibility 1
Telemetry discrepancy 1
Stopcock valve, failure of 1
Incomplete or missing packaging 1
Fitting problem 1
Material perforation 1
Collapse 1
Decrease in suction 1
Deflation due to damage from surgical instrument 1
Failure to deploy 1
Disconnection 1
Dislodged 1
Dissection 1
Device Difficult to Setup or Prepare 1
Peeled 1
Migration of device or device component 1
Occlusion within device 1
Lead(s), breakage of 1
Fluid leak 1
Total Device Problems 1150

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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