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TPLC
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show TPLC since
2009
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Device
system, photopheresis, extracorporeal
Product Code
LNR
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
4
1
7
5
7
2
5
5
8
4
2
1
2
3
3
0
MDR Year
MDR Reports
MDR Events
2014
377
377
2015
319
319
2016
318
318
2017
261
261
2018
183
183
2019
161
161
2020
141
141
2021
114
114
2022
97
97
2023
83
83
2024
25
25
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
845
845
Leak/Splash
659
659
Device Displays Incorrect Message
564
564
Break
408
408
Adverse Event Without Identified Device or Use Problem
151
151
Device Alarm System
90
90
Noise, Audible
82
82
Air Leak
55
55
Device Contamination with Body Fluid
55
55
Device Operates Differently Than Expected
52
52
Detachment Of Device Component
41
41
Crack
41
41
Occlusion Within Device
28
28
Hole In Material
26
26
Insufficient Information
22
22
Improper or Incorrect Procedure or Method
21
21
Coagulation in Device or Device Ingredient
18
18
Device Dislodged or Dislocated
18
18
Detachment of Device or Device Component
18
18
Disconnection
17
17
Pressure Problem
17
17
Protective Measures Problem
16
16
Use of Device Problem
14
14
Material Puncture/Hole
12
12
Gas/Air Leak
11
11
Loose or Intermittent Connection
11
11
Torn Material
11
11
Material Fragmentation
10
10
Unintended Ejection
10
10
Obstruction of Flow
9
9
Output Problem
9
9
Defective Alarm
9
9
Display or Visual Feedback Problem
8
8
Visual Prompts will not Clear
8
8
Burst Container or Vessel
8
8
Bent
7
7
Infusion or Flow Problem
7
7
Failure to Prime
7
7
Material Separation
7
7
Loss of Power
6
6
Device Emits Odor
6
6
Split
6
6
Component Falling
5
5
Positioning Problem
5
5
Moisture or Humidity Problem
4
4
Malposition of Device
4
4
Material Rupture
4
4
Kinked
4
4
Cut In Material
4
4
Sticking
4
4
Air/Gas in Device
4
4
Fitting Problem
4
4
Material Twisted/Bent
4
4
Defective Component
4
4
Vibration
4
4
Physical Property Issue
4
4
Increase in Pressure
4
4
High Test Results
3
3
Smoking
3
3
Component Missing
3
3
Structural Problem
3
3
Unexpected Therapeutic Results
3
3
False Alarm
3
3
Contamination
3
3
Partial Blockage
3
3
Complete Blockage
3
3
Misassembly by Users
3
3
Expulsion
3
3
Device Slipped
3
3
Filling Problem
3
3
Failure to Shut Off
3
3
Improper Flow or Infusion
3
3
Insufficient Flow or Under Infusion
3
3
Thermal Decomposition of Device
2
2
Volume Accuracy Problem
2
2
Free or Unrestricted Flow
2
2
Mechanical Problem
2
2
Inadequate User Interface
2
2
Missing Value Reason
2
2
Defective Device
2
2
Material Protrusion/Extrusion
2
2
Installation-Related Problem
2
2
Excess Flow or Over-Infusion
2
2
Device Contamination with Chemical or Other Material
2
2
Chemical Spillage
2
2
Misconnection
2
2
Device Inoperable
2
2
Fracture
2
2
False Reading From Device Non-Compliance
2
2
Difficult to Remove
2
2
Problem with Software Installation
2
2
Patient-Device Incompatibility
2
2
No Display/Image
2
2
Incorrect Measurement
2
2
Material Split, Cut or Torn
2
2
No Audible Alarm
2
2
Particulates
2
2
Fogging
2
2
Appropriate Term/Code Not Available
2
2
Material Frayed
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
866
866
No Clinical Signs, Symptoms or Conditions
316
316
Blood Loss
211
211
No Consequences Or Impact To Patient
204
204
Hemorrhage/Bleeding
120
120
No Information
53
53
No Code Available
53
53
Low Blood Pressure/ Hypotension
50
50
Dyspnea
37
37
Pulmonary Embolism
32
32
Thrombosis
27
27
Nausea
20
20
Death
20
21
Anemia
19
19
Tachycardia
17
17
Malaise
16
16
Unspecified Infection
14
14
Thrombus
14
14
Chest Pain
13
13
Dizziness
12
12
No Patient Involvement
12
12
Low Oxygen Saturation
12
12
Patient Problem/Medical Problem
11
11
Insufficient Information
11
11
Fever
10
10
Swelling
10
10
High Blood Pressure/ Hypertension
10
10
Pain
9
9
Hypoxia
9
9
Fainting
9
9
Vomiting
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Fatigue
8
8
Headache
7
7
Test Result
7
7
Pallor
7
7
Tingling
7
7
Complaint, Ill-Defined
6
6
Chills
5
5
Reaction
5
5
Weakness
5
5
Respiratory Failure
5
5
Multiple Organ Failure
5
5
Hyperglycemia
5
5
Abdominal Pain
5
5
Itching Sensation
5
5
Respiratory Distress
5
5
Sepsis
4
4
Hypoglycemia
4
4
Bacterial Infection
4
4
Diarrhea
4
4
Hypersensitivity/Allergic reaction
4
4
Hemolysis
4
4
Numbness
4
4
Loss of consciousness
3
3
Sweating
3
3
Discomfort
3
3
Anxiety
3
3
Blurred Vision
3
3
Hematuria
3
3
Ambulation Difficulties
3
3
Paresthesia
3
3
Cyanosis
3
3
Stroke/CVA
3
3
Exposure to Body Fluids
3
3
Air Embolism
3
3
Seizures
3
3
Pulmonary Edema
3
3
Rash
3
3
Skin Discoloration
3
3
Shock
2
2
Pulmonary Infarction
2
2
Pneumonia
2
2
Internal Organ Perforation
2
2
Bradycardia
2
2
Atrial Fibrillation
2
2
Edema
2
2
Erythema
2
2
Hematoma
2
2
Syncope/Fainting
2
2
Cough
2
2
Wheezing
2
2
Confusion/ Disorientation
2
2
Therapeutic Effects, Unexpected
2
2
Burning Sensation
2
2
Brain Injury
2
2
Toxicity
2
2
Chest Tightness/Pressure
2
2
Neck Pain
2
2
Collapse
2
2
Fungal Infection
1
1
Bronchopneumonia
1
1
Reinfusion
1
1
Distress
1
1
Urticaria
1
1
Heart Failure
1
1
Hypoxia in Utero
1
1
Twitching
1
1
Electrolyte Imbalance
1
1
Hot Flashes/Flushes
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Mallinckrodt Pharmaceuticals Ireland Ltd
II
Feb-07-2022
2
Therakos Inc
II
Apr-05-2016
3
Therakos Inc
II
Jul-19-2011
4
Therakos Inc
II
Apr-28-2011
5
Therakos Inc
II
May-26-2010
6
Therakos, Inc.
II
Nov-05-2021
7
Therakos, Inc.
II
Jan-11-2012
8
Therakos, Inc.
II
Aug-10-2011
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