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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 29

Device Problems
Adverse Event Without Identified Device or Use Problem 7970
Device Operates Differently Than Expected 3960
Pumping Stopped 3707
Insufficient Flow or Under Infusion 2866
Device Displays Incorrect Message 2395
Material Integrity Problem 2306
Migration or Expulsion of Device 1756
Insufficient Information 1693
Volume Accuracy Problem 1657
Aspiration Issue 1467
Infusion or Flow Problem 1296
Failure To Service 1209
Intermittent Infusion 1178
Improper or Incorrect Procedure or Method 1177
Unstable 1123
Filling Problem 960
Electromagnetic Interference 882
Obstruction of Flow 818
Use of Device Problem 804
Inappropriate or Unexpected Reset 771
Fluid Leak 747
Excess Flow or Over-Infusion 716
Occlusion Within Device 595
Kinked 501
Disconnection 378
No Audible Alarm 352
Human-Device Interface Problem 295
Device Or Device Fragments Location Unknown 286
Device Alarm System 276
Positioning Problem 224
Premature Elective Replacement Indicator 219
Nonstandard device 209
Battery Problem 183
Communication or Transmission Problem 176
Device Ingredient or Reagent Problem 171
Failure to Disconnect 165
Data Problem 157
Improper Flow or Infusion 148
Protective Measures Problem 141
Mechanical Jam 128
Appropriate Term/Code Not Available 117
Malposition of device 107
Failure to Interrogate 97
Difficult to Advance 81
Patient Device Interaction Problem 79
Connection Problem 79
Application Program Problem 75
Difficult to Interrogate 63
Inadequacy of Device Shape and/or Size 57
Device Operational Issue 54
Activation Failure Including Expansion Failures 53
Device Issue 50
Temperature Problem 42
Misconnection 35
Torn Material 35
Premature End-of-Life Indicator 34
Vibration 32
Material Split, Cut or Torn 32
Catheter 29
Activation, Positioning or Separation Problem 28
No Flow 27
Shelf Life Exceeded 26
Ambient Temperature Problem 22
Noise, Audible 21
Increase in Pressure 19
Decrease in Pressure 17
Environmental Compatibility Problem 17
Mechanical Problem 15
Material Deformation 15
Particulates 15
Leak / Splash 15
Unintended Electrical Shock 14
Overfill 13
Component Missing 12
Display or Visual Feedback Problem 11
Contamination During Use 10
Migration 9
Excessive Heating 9
Material Puncture / Hole 9
Pump 8
Missing Value Reason 8
Difficult To Position 8
Difficult to Insert 8
Inadequate or Insufficient Training 8
Pumping Problem 7
Off-Label Use 7
Changes In Ambient Temperature In Device Environment 7
Device Handling Problem 7
Material Too Rigid or Stiff 7
Device Damaged by Another Device 7
Low Battery 6
Defective Device 6
Detachment Of Device Component 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 47674

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 Inc. II Jun-03-2020
6 Medtronic Neuromodulation I Dec-03-2019
7 Medtronic Neuromodulation II Mar-03-2018
8 Medtronic Neuromodulation III Feb-06-2018
9 Medtronic Neuromodulation II Mar-29-2017
10 Medtronic Neuromodulation I Dec-19-2016
11 Medtronic Neuromodulation II Mar-29-2016
12 Medtronic Neuromodulation II May-28-2015
13 Smiths Medical ASD Inc. II Sep-23-2019

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