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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
pump, infusion, implanted, programmable
Product Code
LKK
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
57
49
32
32
19
16
MDR Year
MDR Reports
MDR Events
2019
5652
5652
2020
5115
5115
2021
4713
4713
2022
4310
4310
2023
4042
4042
2024
3093
3093
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
7438
7438
Infusion or Flow Problem
3953
3953
Insufficient Flow or Under Infusion
3699
3699
Insufficient Information
3536
3536
Migration or Expulsion of Device
3155
3155
Pumping Stopped
2812
2813
Material Integrity Problem
2412
2412
Obstruction of Flow
2231
2231
Electromagnetic Interference
1177
1177
Filling Problem
916
916
Improper or Incorrect Procedure or Method
906
906
Fluid/Blood Leak
777
777
Use of Device Problem
723
723
Excess Flow or Over-Infusion
655
655
Improper Flow or Infusion
442
442
Communication or Transmission Problem
381
381
Positioning Problem
330
330
Disconnection
328
328
Device Alarm System
301
302
Patient Device Interaction Problem
191
191
Device Ingredient or Reagent Problem
161
161
No Audible Alarm
161
161
Failure to Disconnect
151
151
Data Problem
145
145
Human-Device Interface Problem
137
137
Protective Measures Problem
115
115
Appropriate Term/Code Not Available
109
109
Migration
101
101
Material Split, Cut or Torn
101
101
Connection Problem
96
96
Inappropriate or Unexpected Reset
87
87
Difficult to Advance
82
82
Battery Problem
80
80
Application Program Problem
67
67
Failure to Interrogate
65
65
No Flow
64
64
Charging Problem
58
58
Inadequacy of Device Shape and/or Size
54
54
Premature Elective Replacement Indicator
50
50
Ambient Temperature Problem
47
47
Misconnection
45
45
Material Twisted/Bent
44
44
Device Dislodged or Dislocated
38
38
Leak/Splash
31
31
Mechanical Problem
30
30
Fracture
28
28
Material Deformation
25
25
Vibration
24
24
Excessive Heating
23
23
Unintended Electrical Shock
21
21
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7380
7381
No Known Impact Or Consequence To Patient
4261
4261
Pain
4164
4164
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2528
2528
Unspecified Infection
2098
2098
Insufficient Information
1984
1984
Therapeutic Response, Decreased
1857
1857
Muscular Rigidity
1475
1475
Seroma
815
815
Discomfort
753
753
Complaint, Ill-Defined
749
749
Cerebrospinal Fluid Leakage
727
727
Therapeutic Effects, Unexpected
668
668
Nausea
520
520
Malaise
504
504
Headache
490
490
Inadequate Pain Relief
479
479
Wound Dehiscence
449
449
Cognitive Changes
431
431
Overdose
425
425
Vomiting
417
417
Pocket Erosion
409
409
Loss of consciousness
384
384
Swelling/ Edema
372
372
Erythema
356
356
Ambulation Difficulties
340
340
Fluid Discharge
331
331
Fatigue
329
329
Cramp(s) /Muscle Spasm(s)
293
293
Muscle Weakness
264
264
Itching Sensation
259
259
Granuloma
255
255
Numbness
247
247
Fever
247
247
Post Operative Wound Infection
238
238
Muscle Spasm(s)
219
219
Bacterial Infection
219
219
Sleep Dysfunction
218
218
Scar Tissue
202
202
Impaired Healing
197
197
Shaking/Tremors
196
196
Device Embedded In Tissue or Plaque
188
188
Swelling
186
186
Purulent Discharge
177
177
Burning Sensation
173
173
Diarrhea
172
172
Lethargy
170
170
Dizziness
163
163
Diaphoresis
162
162
Anxiety
150
150
Recalls
Manufacturer
Recall Class
Date Posted
1
Flowonix Medical Inc
II
Jul-01-2021
2
Flowonix Medical Inc
II
Feb-10-2020
3
Flowonix Medical Inc
II
Jun-03-2019
4
Intera Oncology, Inc.
I
Aug-22-2022
5
Medtronic Inc.
II
Dec-09-2023
6
Medtronic Inc.
II
Jun-03-2020
7
Medtronic Neuromodulation
II
Jul-12-2024
8
Medtronic Neuromodulation
II
Dec-22-2023
9
Medtronic Neuromodulation
I
Dec-03-2019
10
Smiths Medical ASD Inc.
II
Sep-23-2019
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