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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device graft, vascular, synthetic/biologic composite
Regulation Description Vascular graft prosthesis.
Product CodeMAL
Regulation Number 870.3450
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 29
Device remains implanted 22
Hole in material 11
Unknown (for use when the device problem is not known) 5
Device packaging compromised 4
Material puncture 4
Material frayed 3
No Information 3
Foreign material present in device 2
Manufacturing or shipping issue associated with device 2
Material discolored 2
Other (for use when an appropriate device code cannot be identified) 2
Tears, rips, holes in device, device material 2
Unraveled material 1
Repair 1
Replace 1
Size incorrect for patient 1
Elective replacement 1
Fluid leak 1
Foreign material 1
Contamination during use 1
Product quality issue 1
Material deformation 1
Material integrity issue 1
No Known Device Problem 1
Packaging issue 1
Torn material 1
Human-Device Interface Issue 1
No code available 1
Out-of-box failure 1
Implant, removal of 1
Device Issue 1
Deterioration of prosthesis 1
Structural problem 1
Device, removal of (non-implant) 1
Delamination 1
Device operates differently than expected 1
Total Device Problems 115

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

Recalls
Manufacturer Recall Class Date Posted
1 LeMaitre Vascular, Inc. I Jul-22-2013
2 Maquet Cardiovascular, LLC II Jul-22-2010
3 Vascutek, Ltd. II Jun-26-2015

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