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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 3
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 223
Detachment of device component 119
Kinked 60
Material separation 58
Tip breakage 49
Deflation issue 42
No Known Device Problem 32
Detachment of device or device component 29
Fracture 28
Material rupture 28
Material fragmentation 27
Device, or device fragments remain in patient 23
Aspiration issue 23
Material deformation 21
Difficult to remove 21
Shipping damage or problem 21
Entrapment of device or device component 20
Balloon burst 20
Device damaged prior to use 18
Balloon rupture 15
Component(s), broken 15
Leak 15
Tears, rips, holes in device, device material 14
Out-of-box failure 12
Burst 12
Device displays error message 12
Failure to advance 11
Decoupling 11
Difficult to insert 10
Unraveled material 10
Stretched 9
Hole in material 9
Bent 9
Tear, rip or hole in device packaging 9
Device operates differently than expected 9
Device packaging compromised 9
Unsealed device packaging 8
Retraction problem 7
Contamination during use 7
Difficult to advance 7
Physical resistance 7
Crack 5
Seal, defective 5
Material puncture 4
Slippage of device or device component 4
No code available 4
Dislodged or dislocated 3
Material integrity issue 3
Defective item 3
Device or device fragments location unknown 3
Malfunction 3
Shaft break 3
Defective component 3
Component missing 3
Use of Device Issue 3
Device inoperable 3
Other (for use when an appropriate device code cannot be identified) 3
Inflation issue 3
Foreign material 2
Mechanical issue 2
Blockage within device or device component 2
Balloon leak(s) 2
Collapse 2
Unknown (for use when the device problem is not known) 2
Improper or incorrect procedure or method 2
Source, detachment from 2
Sterility 2
Sticking 2
Loss of power 2
Cut in material 2
Wire(s), breakage of 2
Device Issue 2
Split 2
Device or device component damaged by another device 2
Buckled material 2
Malposition of device 2
Folded 2
Material twisted 2
Foreign material present in device 2
Torn material 2
Positioning Issue 1
Incompatibility problem 1
Mechanical jam 1
Patient-device incompatibility 1
Deployment issue 1
Device Difficult to Setup or Prepare 1
Peeled 1
Telemetry discrepancy 1
Fitting problem 1
Material perforation 1
Incomplete or missing packaging 1
Stopcock valve, failure of 1
Decrease in suction 1
Deflation due to damage from surgical instrument 1
Failure to deploy 1
Disconnection 1
Dislodged 1
Dissection 1
Migration of device or device component 1
Occlusion within device 1
Total Device Problems 1211

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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