• 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 shunt, central nervous system and components
Regulation Description Central nervous system fluid shunt and components.
Product CodeJXG
Regulation Number 882.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 9
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 23
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 18
INTEGRA
  SUBSTANTIALLY EQUIVALENT 27
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 7
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 19
NEUROCARE GROUP
  SUBSTANTIALLY EQUIVALENT 1
NMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
PHOENIX BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 11
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 3
SOPHYSA SA
  SUBSTANTIALLY EQUIVALENT 7
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Other (for use when an appropriate device code cannot be identified) 1055
Leak 627
Break 511
Occlusion within device 510
Explanted 302
No Known Device Problem 260
Program, failure to 254
Performance 253
Device operates differently than expected 252
Blockage within device or device component 244
Programming issue 209
No code available 191
No Information 175
No flow 148
Device Issue 118
Inaccurate flowrate 106
Fracture 101
Disconnection 100
Restricted flowrate 77
Use of Device Issue 75
Excess flow or overinfusion 72
Mechanical issue 62
Dislodged or dislocated 60
Improper flow or infusion 57
Pressure issue 55
Insufficient flow or underinfusion 55
Tears, rips, holes in device, device material 54
Obstruction within device 53
Migration of device or device component 45
Valve(s), failure of 36
Mechanical jam 34
Malfunction 31
Difficult to Program or Calibrate 30
Crack 20
Cut in material 19
Hole in material 17
Device damaged prior to use 16
Device, or device fragments remain in patient 14
Reflux within device 13
Decrease in pressure 13
Infusion or flow issue 13
Connection issue 11
Detachment of device or device component 10
Material separation 10
Shunts, failure of 9
Kinked 9
Fluid leak 8
Torn material 8
Unknown (for use when the device problem is not known) 7
Overheating of device or device component 7
Failure to prime 7
Product quality issue 7
Device remains implanted 6
Air leak 6
Detachment of device component 6
Device or device fragments location unknown 6
Foreign material present in device 6
Defective item 5
Device disinfection or sterilization issue 5
Device inoperable 5
Bent 5
Loose or intermittent connection 5
Material rupture 5
Valve(s), sticking 5
Sticking 5
Difficult to remove 4
Failure to flush 4
Filling problem 4
Split 4
Physical resistance 4
Device displays error message 4
Packaging issue 4
Item contaminated during manufacturing or shipping 3
Improper device output 3
Improper or incorrect procedure or method 3
Failure to pump 3
Material puncture 3
Output above specifications 2
Retraction problem 2
Sterility 2
Material fragmentation 2
Material frayed 2
Loss of or failure to bond 2
Blocked connection 2
Malposition of device 2
Device markings issue 2
Device or device component damaged by another device 2
Component missing 2
Difficult to advance 2
Incorrect device or component shipped 2
Free or unrestricted flow 2
Failure to auto stop 2
Material integrity issue 2
Positioning Issue 2
Unintended movement 2
Device handling issue 2
Noise, Audible 2
Output below specifications 1
Filtration issue 1
Implant, reprogramming of 1
Total Device Problems 6586

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 1 1 0 0 0 0 1 0 0 1
Class II 0 0 1 0 0 2 3 8 1 1 1
Class III 0 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Integra Neuro Sciences II Sep-08-2009
2 Aesculap, Inc. II Jan-26-2015
3 Aesculap, Inc. III Dec-16-2014
4 Aesculap, Inc. II Dec-03-2014
5 Aesculap, Inc. II Jun-02-2014
6 Aesculap, Inc. II Feb-19-2014
7 Aesculap, Inc. II Feb-12-2013
8 Codman & Shurtleff, Inc. II Oct-20-2014
9 Codman & Shurtleff, Inc. II Aug-12-2014
10 Codman & Shurtleff, Inc. II Apr-17-2014
11 Codman & Shurtleff, Inc. II Jan-29-2014
12 Integra LifeSciences Corp II Jul-10-2012
13 Integra LifeSciences Corp. II Sep-30-2016
14 Integra LifeSciences Corp. II Jan-03-2014
15 Integra LifeSciences Corp. I Dec-12-2008
16 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Dec-20-2013
17 Integra Neurosciences PR, Inc. II Feb-16-2012
18 Medtronic Neurosurgery I Apr-07-2017
19 Medtronic Neurosurgery II Feb-02-2017
20 Medtronic Neurosurgery I Jun-27-2014
21 Medtronic Neurosurgery II Nov-26-2013
22 Medtronic Neurosurgery I Mar-27-2009

-
-