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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 53

Device Problems
Adverse Event Without Identified Device or Use Problem 7439
Device Operates Differently Than Expected 4021
Pumping Stopped 3359
Insufficient Flow or Under Infusion 2436
Device Displays Incorrect Message 2419
Material Integrity Problem 2115
Volume Accuracy Problem 1693
Migration or Expulsion of Device 1505
Aspiration Issue 1495
Insufficient Information 1362
Failure To Service 1214
Intermittent Infusion 1192
Unstable 1143
Improper or Incorrect Procedure or Method 1125
Infusion or Flow Problem 1004
Filling Problem 869
Electromagnetic Interference 775
Inappropriate or Unexpected Reset 763
Fluid Leak 686
Excess Flow or Over-Infusion 653
Use of Device Problem 647
Obstruction of Flow 614
Occlusion Within Device 605
Kinked 516
Disconnection 359
No Audible Alarm 338
Device Or Device Fragments Location Unknown 297
Human-Device Interface Problem 271
Device Alarm System 260
Nonstandard device 220
Premature Elective Replacement Indicator 212
Positioning Problem 201
Battery Problem 180
Device Ingredient or Reagent Problem 158
Communication or Transmission Problem 152
Failure to Disconnect 151
Data Problem 138
Protective Measures Problem 133
Mechanical Jam 128
Improper Flow or Infusion 123
Malposition of device 107
Failure to Interrogate 97
Appropriate Term/Code Not Available 95
Difficult to Advance 73
Application Program Problem 72
Connection Problem 72
Difficult to Interrogate 66
Patient Device Interaction Problem 59
Activation Failure Including Expansion Failures 54
Device Operational Issue 54
Inadequacy of Device Shape and/or Size 53
Device Issue 50
Temperature Problem 42
Torn Material 40
Premature End-of-Life Indicator 34
Misconnection 32
Vibration 31
Activation, Positioning or Separation Problem 28
Material Split, Cut or Torn 27
Catheter 27
Shelf Life Exceeded 26
No Flow 25
Increase in Pressure 20
Noise, Audible 18
Environmental Compatibility Problem 17
Material Deformation 16
Decrease in Pressure 16
Ambient Temperature Problem 16
Leak / Splash 15
Mechanical Problem 14
Material Puncture / Hole 13
Overfill 13
Unintended Electrical Shock 12
Component Missing 12
Display or Visual Feedback Problem 11
Particulates 10
Contamination During Use 9
Inadequate or Insufficient Training 8
Difficult To Position 8
Missing Value Reason 8
Pump 8
Material Too Rigid or Stiff 7
Changes In Ambient Temperature In Device Environment 7
Pumping Problem 7
Off-Label Use 7
Difficult to Insert 6
Extrusion 6
Excessive Heating 6
Device Handling Problem 6
Bent 6
Device Damaged by Another Device 6
Defective Device 6
Detachment Of Device Component 6
Low Battery 6
Unintended Movement 5
Difficult or Delayed Positioning 5
Migration 5
Separation Failure 4
Labelling, Instructions for Use or Training Problem 4
Detachment of Device or device Component 4
Total Device Problems 44488

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 I Dec-03-2019
6 Medtronic Neuromodulation II Mar-03-2018
7 Medtronic Neuromodulation III Feb-06-2018
8 Medtronic Neuromodulation II Mar-29-2017
9 Medtronic Neuromodulation I Dec-19-2016
10 Medtronic Neuromodulation II Mar-29-2016
11 Medtronic Neuromodulation II May-28-2015
12 Medtronic Neuromodulation II Aug-08-2014
13 Medtronic Neuromodulation II Jun-04-2014
14 Medtronic Neuromodulation II May-08-2014
15 Medtronic Neuromodulation II May-08-2014
16 Smiths Medical ASD Inc. II Sep-23-2019

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