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TPLC
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show TPLC since
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Device
pump, infusion, implanted, programmable
Product Code
LKK
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
49
32
32
19
22
9
MDR Year
MDR Reports
MDR Events
2020
5115
5115
2021
4713
4713
2022
4310
4310
2023
4041
4041
2024
4619
4619
2025
2385
2385
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
6868
6868
Infusion or Flow Problem
3728
3728
Insufficient Information
3189
3189
Insufficient Flow or Under Infusion
3132
3132
Migration or Expulsion of Device
2961
2961
Pumping Stopped
2196
2196
Material Integrity Problem
2178
2178
Obstruction of Flow
2070
2070
Communication or Transmission Problem
1175
1175
Electromagnetic Interference
1107
1107
Filling Problem
821
821
Improper or Incorrect Procedure or Method
777
777
Fluid/Blood Leak
713
713
Excess Flow or Over-Infusion
597
597
Device Alarm System
486
486
Improper Flow or Infusion
409
409
Use of Device Problem
348
348
Positioning Problem
312
312
Disconnection
305
305
Application Program Problem
268
268
Charging Problem
236
236
Patient Device Interaction Problem
171
171
Data Problem
163
163
Protective Measures Problem
142
142
Failure to Disconnect
142
142
No Audible Alarm
138
138
Device Ingredient or Reagent Problem
131
131
Human-Device Interface Problem
105
105
Migration
98
98
Battery Problem
94
94
Material Split, Cut or Torn
85
85
Appropriate Term/Code Not Available
84
84
Connection Problem
82
82
Inappropriate or Unexpected Reset
78
78
Difficult to Advance
67
67
No Flow
60
60
Failure to Interrogate
57
57
Inadequacy of Device Shape and/or Size
56
56
Display or Visual Feedback Problem
47
47
Material Twisted/Bent
45
45
Ambient Temperature Problem
40
40
Device Dislodged or Dislocated
38
38
Premature Elective Replacement Indicator
37
37
Misconnection
33
33
Fracture
29
29
Leak/Splash
28
28
Failure to Power Up
24
24
Mechanical Problem
22
22
Material Deformation
20
20
Excessive Heating
20
20
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
9705
9705
Pain
3703
3703
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3038
3038
Insufficient Information
2207
2207
No Known Impact Or Consequence To Patient
1936
1936
Unspecified Infection
1936
1936
Muscular Rigidity
1283
1283
Therapeutic Response, Decreased
844
844
Seroma
747
747
Cerebrospinal Fluid Leakage
656
656
Discomfort
653
653
Headache
470
470
Nausea
429
429
Inadequate Pain Relief
423
423
Swelling/ Edema
420
420
Wound Dehiscence
420
420
Malaise
383
383
Pocket Erosion
380
380
Cognitive Changes
379
379
Vomiting
335
335
Cramp(s) /Muscle Spasm(s)
334
334
Loss of consciousness
320
320
Erythema
320
320
Complaint, Ill-Defined
308
308
Ambulation Difficulties
299
299
Fluid Discharge
290
290
Therapeutic Effects, Unexpected
286
286
Fatigue
272
272
Muscle Weakness
245
245
Itching Sensation
231
231
Post Operative Wound Infection
222
222
Fever
212
212
Numbness
208
208
Bacterial Infection
206
206
Impaired Healing
188
188
Granuloma
187
187
Scar Tissue
187
187
Diaphoresis
186
186
Sleep Dysfunction
175
175
Overdose
166
166
Device Embedded In Tissue or Plaque
162
162
Purulent Discharge
158
158
Shaking/Tremors
152
152
Lethargy
139
139
Burning Sensation
136
136
Diarrhea
135
135
Convulsion/Seizure
135
135
Dizziness
134
134
Anxiety
129
129
Confusion/ Disorientation
105
105
Recalls
Manufacturer
Recall Class
Date Posted
1
Flowonix Medical Inc
II
Jul-01-2021
2
Flowonix Medical Inc
II
Feb-10-2020
3
Intera Oncology, Inc.
I
Aug-22-2022
4
Medtronic Inc.
II
Dec-09-2023
5
Medtronic Inc.
II
Jun-03-2020
6
Medtronic Neuromodulation
II
Apr-01-2025
7
Medtronic Neuromodulation
II
Dec-27-2024
8
Medtronic Neuromodulation
II
Oct-21-2024
9
Medtronic Neuromodulation
II
Jul-12-2024
10
Medtronic Neuromodulation
II
Dec-22-2023
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