Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
pump, infusion, enteral
Product Code
LZH
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACACIA, INC.
SUBSTANTIALLY EQUIVALENT
1
AMSINO INTERNATIONAL INC.
SUBSTANTIALLY EQUIVALENT
2
CARDINAL HEALTH LLC
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
3
VESCO MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
ZEVEX, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
116
116
2015
83
83
2016
1248
1248
2017
2620
2620
2018
1651
1651
2019
742
742
2020
1460
1460
2021
1218
1218
2022
526
526
2023
284
284
2024
89
89
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
1843
1843
Protective Measures Problem
1252
1252
No Audible Alarm
961
961
No Display/Image
831
831
Excess Flow or Over-Infusion
740
740
Loss of Power
671
671
Device Alarm System
364
364
Failure to Deliver
335
335
Insufficient Flow or Under Infusion
322
322
Leak/Splash
237
237
Air/Gas in Device
213
213
Device Operates Differently Than Expected
208
208
Inaccurate Delivery
195
195
Inaccurate Flow Rate
185
185
Failure to Auto Stop
183
183
Thermal Decomposition of Device
178
178
Volume Accuracy Problem
178
178
Infusion or Flow Problem
166
166
Detachment of Device or Device Component
125
125
Use of Device Problem
122
122
Display or Visual Feedback Problem
113
113
Device Displays Incorrect Message
100
100
Mechanical Problem
88
88
Break
83
83
Device Stops Intermittently
79
79
Detachment Of Device Component
76
76
Improper Flow or Infusion
75
75
Failure to Power Up
58
58
Defective Alarm
57
57
Overheating of Device
40
40
Disconnection
39
39
Occlusion Within Device
39
39
Human-Device Interface Problem
36
36
Delayed Alarm
34
34
Pumping Problem
31
31
Increased Pump Speed
29
29
Self-Activation or Keying
27
27
Decreased Pump Speed
25
25
Defective Component
21
21
Connection Problem
20
20
Improper or Incorrect Procedure or Method
18
18
Power Problem
18
18
Pumping Stopped
18
18
Defective Device
17
17
Failure to Charge
17
17
Melted
17
17
No Flow
16
16
Smoking
15
15
Adverse Event Without Identified Device or Use Problem
15
15
Battery Problem
15
15
Fire
15
15
Device Inoperable
14
14
Appropriate Term/Code Not Available
13
13
Material Separation
13
13
Air Leak
12
12
Complete Blockage
12
12
Device Slipped
12
12
Free or Unrestricted Flow
12
12
Improper Device Output
12
12
Sparking
12
12
Failure to Prime
11
11
Power Conditioning Problem
11
11
Obstruction of Flow
11
11
Premature Discharge of Battery
11
11
Noise, Audible
11
11
Incorrect Or Inadequate Test Results
11
11
Poor Quality Image
11
11
Hole In Material
10
10
Failure to Infuse
9
9
Insufficient Information
9
9
Output Problem
9
9
Loose or Intermittent Connection
9
9
Electrical Power Problem
9
9
Incorrect Measurement
9
9
Programming Issue
9
9
Device Dislodged or Dislocated
8
8
Electrical /Electronic Property Problem
8
8
Material Rupture
8
8
Device Emits Odor
8
8
Image Display Error/Artifact
7
7
Mechanics Altered
7
7
Unable to Obtain Readings
7
7
Crack
7
7
Temperature Problem
6
6
No Device Output
6
6
Incorrect, Inadequate or Imprecise Result or Readings
6
6
Kinked
6
6
Use of Incorrect Control/Treatment Settings
6
6
Fail-Safe Problem
6
6
Material Puncture/Hole
6
6
Failure to Pump
6
6
Display Difficult to Read
6
6
Difficult to Remove
5
5
Component Missing
5
5
Device Issue
5
5
Device Handling Problem
5
5
Sticking
5
5
Failure of Device to Self-Test
5
5
Alarm Not Visible
5
5
Failure to Shut Off
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
2542
2542
No Known Impact Or Consequence To Patient
2360
2360
No Consequences Or Impact To Patient
2176
2176
No Clinical Signs, Symptoms or Conditions
2151
2151
No Information
548
548
Insufficient Information
99
99
Vomiting
47
47
No Code Available
45
45
Hypoglycemia
24
25
Dyskinesia
22
22
Overdose
21
21
Not Applicable
21
21
Feeding Problem
18
18
Nausea
16
16
Abdominal Distention
16
16
Discomfort
14
14
Ambulation Difficulties
14
14
Death
12
12
Abdominal Pain
7
7
Pain
7
7
Weight Changes
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Muscle Spasm(s)
6
6
Flatus
6
6
Cognitive Changes
6
6
Shaking/Tremors
6
6
Underdose
5
5
Anxiety
5
5
Dyspnea
5
5
Device Overstimulation of Tissue
5
5
Missed Dose
5
5
Aspiration/Inhalation
4
4
Urinary Retention
4
4
Sleep Dysfunction
4
4
Electric Shock
4
4
Complaint, Ill-Defined
3
3
Malaise
3
3
Burn(s)
3
3
Fatigue
3
3
Hyperglycemia
3
4
Pneumonia
3
3
Unspecified Infection
3
3
Tachycardia
3
3
Patient Problem/Medical Problem
2
2
Pneumothorax
2
2
Fever
2
2
Fall
2
2
Dehydration
2
2
Dementia
2
2
Loss of consciousness
2
2
Lethargy
2
2
Abdominal Cramps
2
2
Visual Disturbances
2
2
Distress
2
2
Weakness
2
2
Tingling
2
2
Twitching
2
2
Respiratory Distress
2
2
Seizures
2
2
Sepsis
1
1
Shock
1
1
Swelling
1
1
Dizziness
1
1
Dysphasia
1
1
Electrolyte Imbalance
1
1
Brain Injury
1
1
Hypernatremia
1
1
Urinary Frequency
1
1
Pressure Sores
1
1
Confusion/ Disorientation
1
1
Choking
1
1
Mitral Valve Prolapse
1
1
Low Oxygen Saturation
1
1
Respiratory Failure
1
1
Sudden Cardiac Death
1
1
Inadequate Pain Relief
1
1
Coma
1
1
Embolism
1
1
Chest Pain
1
1
Air Embolism
1
1
Arrhythmia
1
1
Muscle Stimulation
1
1
Headache
1
1
Loss of Range of Motion
1
1
Muscular Rigidity
1
1
Inflammation
1
1
Irritation
1
1
Hypothermia
1
1
Undesired Nerve Stimulation
1
1
Neurological Deficit/Dysfunction
1
1
Internal Organ Perforation
1
1
Full thickness (Third Degree) Burn
1
1
Device Embedded In Tissue or Plaque
1
1
Blood Loss
1
1
Cancer
1
1
Constipation
1
1
Convulsion/Seizure
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Gastrointestinal Regurgitation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Nutrition, Abbott Laboratories
II
Sep-21-2009
2
CORPAK MedSystems
II
Oct-25-2011
3
Cardinal Health 200, LLC
II
Apr-02-2021
4
Cardinal Health 200, LLC
II
Nov-13-2020
5
Cardinal Health Inc.
II
May-22-2020
6
MOOG Medical Devices Group
II
Jan-31-2013
7
MOOG Medical Devices Group
II
Nov-15-2012
8
Medtronic
II
May-10-2016
9
Zevex International, Inc.
II
Sep-21-2009
-
-