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TPLC
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Device
shunt, central nervous system and components
Regulation Description
Central nervous system fluid shunt and components.
Product Code
JXG
Regulation Number
882.5550
Device Class
2
Premarket Reviews
Manufacturer
Decision
AESCULAP
SUBSTANTIALLY EQUIVALENT
4
AESCULAP, INC.
SUBSTANTIALLY EQUIVALENT
4
AQUEDUCT CRITICAL CARE, INC.
SUBSTANTIALLY EQUIVALENT
3
ARKIS BIOSCIENCES INC.
SUBSTANTIALLY EQUIVALENT
1
BTG INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
CODMAN & SHURTLEFF, INC.
SUBSTANTIALLY EQUIVALENT
3
INTEGRA
SUBSTANTIALLY EQUIVALENT
6
INTEGRA LIFESCIENCES CORP.
SUBSTANTIALLY EQUIVALENT
2
INTEGRA LIFESCIENCES CORPORATION
SUBSTANTIALLY EQUIVALENT
4
JOHNSON & JOHNSON PROFESSIONALS, INC.
SUBSTANTIALLY EQUIVALENT
3
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2016
1087
1087
2017
1331
1331
2018
1478
1478
2019
1295
1295
2020
1206
1206
2021
129
129
Device Problems
MDRs with this Device Problem
Events in those MDRs
Infusion or Flow Problem
701
701
Adverse Event Without Identified Device or Use Problem
554
554
Appropriate Term/Code Not Available
546
546
Break
524
524
Insufficient Information
478
478
Obstruction of Flow
468
468
Device Operates Differently Than Expected
437
437
Occlusion Within Device
330
330
Mechanical Problem
309
309
Programming Issue
234
234
Leak/Splash
229
229
Fluid Leak
214
214
No Flow
114
114
Valve, Flow
113
113
Partial Blockage
112
112
Device Dislodged or Dislocated
110
110
Mechanics Altered
107
107
Fracture
105
105
Disconnection
100
100
Device Operational Issue
97
97
Pressure Problem
91
91
Device Difficult to Program or Calibrate
90
90
Use of Device Problem
90
90
Excess Flow or Over-Infusion
86
86
Inaccurate Flow Rate
79
79
Crack
79
79
Mechanical Jam
76
76
Electrical /Electronic Property Problem
63
63
Improper Flow or Infusion
60
60
Complete Blockage
59
59
Migration or Expulsion of Device
58
58
Insufficient Flow or Under Infusion
57
57
Material Separation
50
50
Defective Device
42
42
Detachment of Device or Device Component
38
38
Migration
37
37
Material Integrity Problem
36
36
Valve(s)
30
30
Detachment Of Device Component
28
28
Blocked Connection
28
28
Material Fragmentation
26
26
Catheter
23
23
Output Problem
22
22
Device Misassembled During Manufacturing /Shipping
22
22
Activation, Positioning or SeparationProblem
20
20
Defective Component
19
19
Overheating of Device
18
18
Loose or Intermittent Connection
15
15
Material Split, Cut or Torn
15
15
Separation Problem
14
14
Overcorrection
14
14
Shunt
14
14
Torn Material
13
13
Positioning Problem
12
12
Connection Problem
12
12
Product Quality Problem
11
11
Material Puncture/Hole
10
10
Incorrect, Inadequate or Imprecise Resultor Readings
10
10
Increase in Pressure
10
10
Failure to Prime
10
10
Air Leak
10
10
Kinked
9
9
Restricted Flow rate
9
9
Difficult to Remove
9
9
Improper or Incorrect Procedure or Method
9
9
Device Inoperable
9
9
Patient-Device Incompatibility
9
9
Device Contamination with Chemical or Other Material
8
8
Free or Unrestricted Flow
8
8
Material Twisted/Bent
8
8
Reset Problem
8
8
Device Or Device Fragments Location Unknown
8
8
Hole In Material
8
8
Flushing Problem
8
8
Transducer
8
8
Valve, Pressure Limit
8
8
Tube
7
7
Component Missing
7
7
Misassembled
7
7
Material Rupture
7
7
Device Appears to Trigger Rejection
7
7
Device Component Or Accessory
7
7
Device Markings/Labelling Problem
7
7
Failure to Auto Stop
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Material Deformation
6
6
Therapeutic or Diagnostic Output Failure
6
6
Tip
6
6
Device Slipped
6
6
Device Displays Incorrect Message
5
5
Malposition of Device
5
5
Failure to Advance
5
5
Separation Failure
5
5
Microbial Contamination of Device
5
5
Decrease in Pressure
5
5
Self-Activation or Keying
5
5
Nonstandard Device
5
5
Wire
5
5
Label
5
5
Material Discolored
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
1604
1604
No Information
1052
1052
Hydrocephalus
599
599
Injury
508
508
Therapeutic Response, Decreased
472
472
Failure of Implant
451
451
Unspecified Infection
433
433
Headache
375
375
No Consequences Or Impact To Patient
180
180
Patient Problem/Medical Problem
178
178
Therapeutic Effects, Unexpected
162
162
Cerebrospinal Fluid Leakage
151
151
Vomiting
148
148
No Code Available
119
119
No Clinical Signs, Symptoms or Conditions
108
108
Ambulation Difficulties
82
82
Pain
71
71
Complaint, Ill-Defined
67
67
Neurological Deficit/Dysfunction
64
64
Hematoma
62
62
Fever
62
62
Nausea
61
61
Dizziness
60
60
Coma
59
59
Device Embedded In Tissue or Plaque
52
52
Death
49
49
Cognitive Changes
49
49
Swelling
38
38
Seizures
35
35
Fatigue
33
33
Lethargy
32
32
Loss of consciousness
29
29
Hemorrhage, Subdural
29
29
Visual Impairment
28
28
Confusion/ Disorientation
28
28
Discomfort
26
26
Bacterial Infection
26
26
Cerebral Ventriculomeglia
22
22
Meningitis
21
21
No Patient Involvement
19
19
Malaise
19
19
Staphylococcus Aureus
19
19
Foreign Body In Patient
18
18
Incontinence
18
18
Hemorrhage/Bleeding
17
17
Dysphasia
17
17
Erosion
17
17
Intracranial Hemorrhage
17
17
Seroma
16
16
Inflammation
15
15
Cyst(s)
15
15
Blurred Vision
14
14
Hemorrhage, Cerebral
13
13
Hypersensitivity/Allergic reaction
12
12
Abdominal Pain
12
12
Edema
11
11
Tissue Damage
11
11
Wound Dehiscence
11
11
Abscess
10
10
Hemorrhage, Intraventricular
10
10
Muscle Weakness
10
10
Insufficient Information
10
10
Brain Injury
10
10
Weakness
9
9
Reaction
9
9
Visual Disturbances
9
9
Vertigo
8
8
Fall
8
8
Memory Loss/Impairment
8
8
Paresis
8
8
High Blood Pressure/ Hypertension
8
8
Dysphagia/ Odynophagia
8
8
Fluid Discharge
8
8
Loss of Vision
8
8
Muscular Rigidity
8
8
Irritability
7
7
Neck Stiffness
7
7
Sleep Dysfunction
7
7
Fungal Infection
7
7
Neck Pain
6
6
Sepsis
6
6
Erythema
6
6
Host-Tissue Reaction
6
6
Irritation
6
6
Ventricle, Abnormality Of
6
6
Paralysis
6
6
Cardiac Arrest
5
5
Tinnitus
5
5
Swelling/ Edema
5
5
Tissue Breakdown
4
4
Tachycardia
4
4
Urinary Tract Infection
4
4
Disability
4
4
Breast Neoplasm
4
4
Stroke/CVA
4
4
Infarction, Cerebral
4
4
Facial Nerve Paralysis
4
4
Foreign Body Reaction
4
4
Low Blood Pressure/ Hypotension
4
4
Hearing Impairment
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Mar-01-2018
2
Integra LifeSciences Corp.
II
Dec-23-2020
3
Integra LifeSciences Corp.
I
May-20-2019
4
Integra LifeSciences Corp.
II
Sep-30-2016
5
Medtronic Neurosurgery
II
Feb-12-2021
6
Medtronic Neurosurgery
II
Jan-15-2021
7
Medtronic Neurosurgery
II
Dec-28-2020
8
Medtronic Neurosurgery
I
Apr-07-2017
9
Medtronic Neurosurgery
II
Feb-02-2017
10
Natus Manufacturing Limited
II
Feb-22-2021
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