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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)
2015 2016 2017 2018 2019 2020
40 30 42 55 57 12

Device Problems
Adverse Event Without Identified Device or Use Problem 7732
Device Operates Differently Than Expected 3960
Pumping Stopped 3529
Insufficient Flow or Under Infusion 2675
Device Displays Incorrect Message 2395
Material Integrity Problem 2221
Volume Accuracy Problem 1657
Migration or Expulsion of Device 1647
Insufficient Information 1555
Aspiration Issue 1467
Failure To Service 1209
Infusion or Flow Problem 1190
Intermittent Infusion 1178
Improper or Incorrect Procedure or Method 1142
Unstable 1123
Filling Problem 917
Electromagnetic Interference 844
Inappropriate or Unexpected Reset 765
Use of Device Problem 735
Obstruction of Flow 724
Fluid Leak 713
Excess Flow or Over-Infusion 687
Occlusion Within Device 595
Kinked 501
Disconnection 371
No Audible Alarm 344
Device Or Device Fragments Location Unknown 286
Human-Device Interface Problem 285
Device Alarm System 269
Premature Elective Replacement Indicator 214
Positioning Problem 212
Nonstandard device 209
Battery Problem 180
Device Ingredient or Reagent Problem 166
Communication or Transmission Problem 164
Failure to Disconnect 159
Data Problem 147
Improper Flow or Infusion 138
Protective Measures Problem 137
Mechanical Jam 128
Appropriate Term/Code Not Available 111
Malposition of device 107
Failure to Interrogate 97
Connection Problem 76
Difficult to Advance 76
Application Program Problem 72
Patient Device Interaction Problem 70
Difficult to Interrogate 63
Inadequacy of Device Shape and/or Size 55
Device Operational Issue 54
Activation Failure Including Expansion Failures 53
Device Issue 50
Temperature Problem 42
Torn Material 35
Misconnection 35
Premature End-of-Life Indicator 34
Vibration 32
Catheter 29
Material Split, Cut or Torn 29
Activation, Positioning or Separation Problem 28
No Flow 26
Shelf Life Exceeded 26
Noise, Audible 19
Increase in Pressure 19
Ambient Temperature Problem 19
Environmental Compatibility Problem 17
Decrease in Pressure 17
Material Deformation 15
Leak / Splash 15
Mechanical Problem 14
Unintended Electrical Shock 13
Overfill 13
Component Missing 12
Display or Visual Feedback Problem 11
Particulates 10
Contamination During Use 10
Migration 9
Material Puncture / Hole 9
Excessive Heating 9
Pump 8
Inadequate or Insufficient Training 8
Missing Value Reason 8
Difficult To Position 8
Difficult to Insert 8
Pumping Problem 7
Device Damaged by Another Device 7
Material Too Rigid or Stiff 7
Off-Label Use 7
Changes In Ambient Temperature In Device Environment 7
Bent 6
Extrusion 6
Device Handling Problem 6
Detachment Of Device Component 6
Low Battery 6
Defective Device 6
Device Markings / Labelling Problem 5
Unintended Movement 5
Separation Failure 5
Difficult or Delayed Positioning 5
No Apparent Adverse Event 5
Total Device Problems 46137

Recalls
Manufacturer Recall Class Date Posted
1 Codman & Shurtleff, Inc. II May-28-2015
2 Flowonix Medical Inc II Feb-10-2020
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 Smiths Medical ASD Inc. II Sep-23-2019

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