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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device pump, infusion, implanted, programmable
Product CodeLKK
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019
27 40 30 42 55 48

Device Problems
Adverse Event Without Identified Device or Use Problem 7233
Device Operates Differently Than Expected 4021
Pumping Stopped 3228
Device Displays Incorrect Message 2419
Insufficient Flow or Under Infusion 2282
Material Integrity Problem 2037
Volume Accuracy Problem 1693
Aspiration Issue 1495
Migration or Expulsion of Device 1407
Insufficient Information 1232
Failure To Service 1214
Intermittent Infusion 1191
Unstable 1143
Improper or Incorrect Procedure or Method 1097
Infusion or Flow Problem 883
Filling Problem 845
Inappropriate or Unexpected Reset 759
Electromagnetic Interference 736
Fluid Leak 660
Excess Flow or Over-Infusion 634
Occlusion Within Device 605
Use of Device Problem 580
Obstruction of Flow 547
Kinked 516
Disconnection 353
No Audible Alarm 330
Device Or Device Fragments Location Unknown 297
Human-Device Interface Problem 263
Device Alarm System 257
Nonstandard device 219
Premature Elective Replacement Indicator 210
Positioning Problem 188
Battery Problem 178
Communication or Transmission Problem 149
Device Ingredient or Reagent Problem 148
Failure to Disconnect 145
Data Problem 136
Protective Measures Problem 131
Mechanical Jam 128
Improper Flow or Infusion 114
Malposition of device 107
Appropriate Term/Code Not Available 95
Failure to Interrogate 95
Application Program Problem 71
Connection Problem 70
Difficult to Advance 69
Difficult to Interrogate 66
Device Operational Issue 54
Patient Device Interaction Problem 54
Activation Failure Including Expansion Failures 54
Inadequacy of Device Shape and/or Size 52
Device Issue 50
Temperature Problem 42
Torn Material 40
Premature End-of-Life Indicator 33
Misconnection 32
Vibration 31
Activation, Positioning or Separation Problem 28
Catheter 27
Shelf Life Exceeded 26
Material Split, Cut or Torn 25
No Flow 24
Increase in Pressure 18
Noise, Audible 18
Environmental Compatibility Problem 17
Decrease in Pressure 16
Material Deformation 15
Leak / Splash 14
Material Puncture / Hole 13
Overfill 13
Ambient Temperature Problem 12
Unintended Electrical Shock 12
Component Missing 11
Display or Visual Feedback Problem 11
Particulates 10
Contamination During Use 9
Pump 8
Difficult To Position 8
Inadequate or Insufficient Training 8
Missing Value Reason 8
Pumping Problem 7
Material Too Rigid or Stiff 7
Off-Label Use 7
Changes In Ambient Temperature In Device Environment 7
Detachment Of Device Component 6
Bent 6
Difficult to Insert 6
Mechanical Problem 6
Device Handling Problem 6
Extrusion 6
Low Battery 6
Defective Device 6
Device Damaged by Another Device 6
Difficult or Delayed Positioning 5
Excessive Heating 5
Unintended Movement 5
Migration 4
Labelling, Instructions for Use or Training Problem 4
Break 4
Device Markings / Labelling Problem 4
Total Device Problems 43182

Recalls
Manufacturer Recall Class Date Posted
1 Codman & Shurtleff, Inc. II May-28-2015
2 Codman & Shurtleff, Inc. II May-09-2014
3 Flowonix Medical Inc II Jun-03-2019
4 Flowonix Medical, Inc. II Jun-19-2017
5 Medtronic Neuromodulation II Mar-03-2018
6 Medtronic Neuromodulation III Feb-06-2018
7 Medtronic Neuromodulation II Mar-29-2017
8 Medtronic Neuromodulation I Dec-19-2016
9 Medtronic Neuromodulation II Mar-29-2016
10 Medtronic Neuromodulation II May-28-2015
11 Medtronic Neuromodulation II Aug-08-2014
12 Medtronic Neuromodulation II Jun-04-2014
13 Medtronic Neuromodulation II May-08-2014
14 Medtronic Neuromodulation II May-08-2014
15 Smiths Medical ASD Inc. II Sep-23-2019

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