• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 226
Detachment of device component 119
Kinked 65
Material separation 60
Tip breakage 49
Deflation issue 42
No Known Device Problem 37
Aspiration issue 32
Detachment of device or device component 29
Fracture 29
Material rupture 29
Material fragmentation 27
Material deformation 24
Device, or device fragments remain in patient 23
Device damaged prior to use 22
Difficult to remove 21
Shipping damage or problem 21
Entrapment of device or device component 21
Balloon burst 20
Device displays error message 18
Leak 17
Out-of-box failure 16
Balloon rupture 15
Component(s), broken 15
Tears, rips, holes in device, device material 14
Burst 12
Failure to advance 12
Decoupling 11
Stretched 11
Unraveled material 10
Difficult to insert 10
Hole in material 10
Bent 9
Unsealed device packaging 9
Tear, rip or hole in device packaging 9
Physical resistance 9
Device operates differently than expected 9
Device packaging compromised 9
Difficult to advance 8
Contamination during use 8
Retraction problem 7
Material integrity issue 7
Material puncture 5
Seal, defective 5
Crack 5
Slippage of device or device component 4
No code available 4
Device handling issue 4
Dislodged or dislocated 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
Decrease in suction 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
Split 2
Wire(s), breakage of 2
Device Issue 2
Buckled material 2
Malposition of device 2
Folded 2
Foreign material present in device 2
Device or device component damaged by another device 2
Material twisted 2
Torn material 2
Mechanical jam 1
Material Distortion 1
Positioning Issue 1
Device-device incompatibility 1
Incompatibility problem 1
Issue with displayed error message 1
Patient-device incompatibility 1
Deployment issue 1
Structural problem 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
Deflation due to damage from surgical instrument 1
Failure to deploy 1
Total Device Problems 1275

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

-
-