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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, infusion, implanted, programmable
Product CodeLKK
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
40 30 42 55 57 11

Device Problems
Adverse Event Without Identified Device or Use Problem 7601
Device Operates Differently Than Expected 3960
Pumping Stopped 3467
Insufficient Flow or Under Infusion 2592
Device Displays Incorrect Message 2395
Material Integrity Problem 2171
Volume Accuracy Problem 1657
Migration or Expulsion of Device 1586
Insufficient Information 1475
Aspiration Issue 1467
Failure To Service 1209
Intermittent Infusion 1178
Improper or Incorrect Procedure or Method 1133
Unstable 1123
Infusion or Flow Problem 1113
Filling Problem 898
Electromagnetic Interference 811
Inappropriate or Unexpected Reset 760
Use of Device Problem 707
Fluid Leak 703
Obstruction of Flow 683
Excess Flow or Over-Infusion 669
Occlusion Within Device 595
Kinked 501
Disconnection 366
No Audible Alarm 339
Device Or Device Fragments Location Unknown 286
Human-Device Interface Problem 280
Device Alarm System 267
Premature Elective Replacement Indicator 212
Nonstandard device 209
Positioning Problem 206
Battery Problem 179
Device Ingredient or Reagent Problem 163
Communication or Transmission Problem 157
Failure to Disconnect 154
Data Problem 141
Protective Measures Problem 136
Improper Flow or Infusion 132
Mechanical Jam 128
Appropriate Term/Code Not Available 109
Malposition of device 107
Failure to Interrogate 96
Connection Problem 74
Difficult to Advance 73
Application Program Problem 72
Patient Device Interaction Problem 66
Difficult to Interrogate 63
Device Operational Issue 54
Inadequacy of Device Shape and/or Size 54
Activation Failure Including Expansion Failures 53
Device Issue 50
Temperature Problem 42
Torn Material 35
Misconnection 34
Premature End-of-Life Indicator 34
Vibration 32
Catheter 29
Activation, Positioning or Separation Problem 28
Material Split, Cut or Torn 28
No Flow 26
Shelf Life Exceeded 26
Increase in Pressure 19
Noise, Audible 19
Environmental Compatibility Problem 17
Decrease in Pressure 16
Ambient Temperature Problem 16
Leak / Splash 15
Material Deformation 15
Mechanical Problem 14
Overfill 13
Unintended Electrical Shock 13
Component Missing 12
Display or Visual Feedback Problem 11
Particulates 10
Contamination During Use 10
Excessive Heating 9
Material Puncture / Hole 9
Pump 8
Missing Value Reason 8
Inadequate or Insufficient Training 8
Difficult To Position 8
Changes In Ambient Temperature In Device Environment 7
Migration 7
Pumping Problem 7
Difficult to Insert 7
Off-Label Use 7
Material Too Rigid or Stiff 7
Device Damaged by Another Device 7
Low Battery 6
Defective Device 6
Detachment Of Device Component 6
Device Handling Problem 6
Bent 6
Extrusion 6
Device Markings / Labelling Problem 5
Difficult or Delayed Positioning 5
Separation Failure 5
No Apparent Adverse Event 5
Material Twisted / Bent 5
Total Device Problems 45354

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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