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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, neurovascular embolization
Regulation Description Neurovascular embolization device.
Product CodeHCG
Regulation Number 882.5950
Device Class 2


Premarket Reviews
ManufacturerDecision
BLOCKADE MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 4
JOHNSON & JOHNSON PROFESSIONALS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 3
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 3
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 6
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Failure to Advance 2312
Physical Resistance 1613
Detachment Of Device Component 1033
Physical Resistance / Sticking 816
Adverse Event Without Identified Device or Use Problem 741
Coil 728
Break 511
Stretched 483
Kinked 440
Premature Activation 430
Separation Failure 407
Positioning Failure 351
Premature Separation 351
Mechanical Jam 312
Device Handling Problem 293
Mechanical Problem 276
Device Operates Differently Than Expected 273
Device Damaged Prior to Use 246
Difficult to Advance 245
Detachment of Device or device Component 241
Material Deformation 228
Migration or Expulsion of Device 212
Bent 177
Retraction Problem 142
Out-Of-Box Failure 139
Difficult or Delayed Activation 122
Device Issue 116
Unraveled Material 105
Difficult To Position 103
Difficult to Remove 100
Failure to Fold 86
Material Protrusion / Extrusion 65
Device-Device Incompatibility 62
Inadequacy of Device Shape and/or Size 62
Material Twisted / Bent 61
Activation, Positioning or Separation Problem 60
Deformation Due to Compressive Stress 56
Difficult or Delayed Positioning 54
Migration 50
Material Separation 50
Appropriate Term/Code Not Available 47
Fracture 46
Entrapment of Device 45
Difficult or Delayed Separation 45
Unintended Movement 31
Device Operational Issue 30
Malposition of device 29
Positioning Problem 27
Device Dislodged or Dislocated 23
Device Fell 23
Material Too Rigid or Stiff 22
Defective Device 22
Insufficient Information 18
Device Damaged by Another Device 16
Use of Device Problem 16
Patient-Device Incompatibility 15
Material Integrity Problem 14
Separation Problem 11
No Apparent Adverse Event 11
Device Difficult to Setup or Prepare 11
Difficult to Insert 10
Knotted 9
Structural Problem 8
Device Markings / Labelling Problem 8
Material Frayed 6
Component Missing 6
Difficult to Fold or Unfold 5
Air Leak 5
Collapse 5
Contamination During Use 5
Component Falling 5
Device Contamination with Chemical or Other Material 5
Partial Blockage 5
Failure to Disconnect 4
Physical Property Issue 4
Noise, Audible 4
Difficult to Open or Remove Packaging Material 3
Unsealed Device Packaging 3
Leak / Splash 3
Improper or Incorrect Procedure or Method 3
Connection Problem 3
Delivery System Failure 3
Folded 3
Inadequate User Interface 3
Catheter 3
Sticking 3
Hub 3
Human Factors Issue 3
Looping 3
Material Disintegration 2
Accessory Incompatible 2
Wire 2
Split 2
None 2
Peeled / Delaminated 2
Uncoiled 2
Torn Material 2
Coagulation in Device or device Ingredient 2
Unintended Ejection 2
Misconnection 2
Total Device Problems 14809

Recalls
Manufacturer Recall Class Date Posted
1 Codman & Shurtleff Inc II Aug-15-2019
2 Stryker Neurovascular II Jul-11-2016
3 Stryker Neurovascular II Apr-19-2016
4 Stryker Neurovascular II Dec-16-2014

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