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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, vascular graft, of 6mm and greater diameter
Regulation Description Vascular graft prosthesis.
Product CodeDSY
Regulation Number 870.3450
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORP.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  SUBSTANTIALLY EQUIVALENT 16
BAXTER HEALTHCARE CORP.
  1
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  4
  SUBSTANTIALLY EQUIVALENT 14
CARBOMEDICS, INC.
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
  1.  K032900  LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS ...
INTER-VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 3
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 5
SULZER
  SUBSTANTIALLY EQUIVALENT 4
TAYSIDE FLOW TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 2
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 3
VASCUTEK LTD.
  3
  SUBSTANTIALLY EQUIVALENT 14
W.L. GORE & ASSOCIATES,INC
  SE - POSTMARKET SURVEILLANCE REQUIRED 1
  5
  SUBSTANTIALLY EQUIVALENT 14

Device Problems
Leak 128
No code available 118
Manufacturing or shipping issue associated with device 58
No Information 48
Device operates differently than expected 43
Occlusion within device 42
No Known Device Problem 37
Other (for use when an appropriate device code cannot be identified) 34
Device remains implanted 34
Device clogged 30
Unknown (for use when the device problem is not known) 23
Tears, rips, holes in device, device material 21
Hole in material 20
Torn material 20
Peeled 16
Mislabeled 14
Foreign material 13
Unraveled material 13
Explanted 11
Delamination 9
Material frayed 7
Product quality issue 6
Migration of device or device component 6
Replace 5
Split 5
Blockage within device or device component 5
Foreign material present in device 5
Kinked 4
Material rupture 4
Material separation 4
Size incorrect for patient 4
Repair 3
Break 3
Detachment of device component 3
Entrapment of device or device component 3
Material deformation 3
Human-Device Interface Issue 2
Device packaging compromised 2
Elective removal 2
Elective replacement 2
Contamination during use 2
Reaction 2
Material puncture 2
Fluid leak 2
Fracture 2
Sticking 2
Stretched 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
Deployment issue 2
Material perforation 2
Fungus in device environment 2
Implant, removal of 1
Surgical graft, failure of 1
Device Issue 1
Tear, rip or hole in device packaging 1
Cut in material 1
Bacterial contamination of device 1
Out-of-box failure 1
Device Contamination with biological material 1
Device markings issue 1
Malposition of device 1
Biological environmental factor 1
Device or device component damaged by another device 1
Device inoperable 1
Suture line separation 1
Difficult to remove 1
Shelf life exceeded 1
Loose or intermittent connection 1
Mechanical issue 1
Melted 1
Nonstandard device or device component 1
Design/structure problem 1
Material discolored 1
Disconnection 1
Electro-magnetic interference (EMI) 1
Coagulation in device or device ingredient 1
Component(s), broken 1
Filling problem 1
Fire 1
Failure to remove enzymatic cleaner 1
Material erosion 1
Device expiration issue 1
Improper flow or infusion 1
Infusion or flow issue 1
Material Distortion 1
Material integrity issue 1
Material Protrusion 1
Total Device Problems 870

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 5 1 0 2 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Sep-30-2013
2 Bard Peripheral Vascular Inc II Feb-09-2016
3 Intervascular S.A.S. II Apr-28-2010
4 Intervascular S.A.S. II Apr-23-2010
5 Maquet Cardiovascular, LLC II Mar-07-2011
6 Maquet Cardiovascular, LLC II Jul-22-2010
7 Maquet Cardiovascular, LLC II May-14-2010
8 Maquet Cardiovascular, LLC II Feb-26-2010
9 Terumo Cardiovascular Systems Corporation II Nov-18-2013
10 Vascutek, Ltd. II Aug-18-2014

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