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
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
Detachment of Device or Device Component
18
18
Device Dislodged or Dislocated
18
18
Coagulation in Device or Device Ingredient
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
Loose or Intermittent Connection
11
11
Torn Material
11
11
Gas/Air Leak
11
11
Unintended Ejection
10
10
Material Fragmentation
10
10
Defective Alarm
9
9
Output Problem
9
9
Obstruction of Flow
9
9
Visual Prompts will not Clear
8
8
Burst Container or Vessel
8
8
Display or Visual Feedback Problem
8
8
Bent
7
7
Failure to Prime
7
7
Material Separation
7
7
Infusion or Flow Problem
7
7
Split
6
6
Loss of Power
6
6
Device Emits Odor
6
6
Component Falling
5
5
Positioning Problem
5
5
Physical Property Issue
4
4
Material Twisted/Bent
4
4
Moisture or Humidity Problem
4
4
Malposition of Device
4
4
Defective Component
4
4
Fitting Problem
4
4
Vibration
4
4
Cut In Material
4
4
Kinked
4
4
Increase in Pressure
4
4
Sticking
4
4
Material Rupture
4
4
Air/Gas in Device
4
4
Unexpected Therapeutic Results
3
3
Device Slipped
3
3
Smoking
3
3
Contamination
3
3
Complete Blockage
3
3
Partial Blockage
3
3
False Alarm
3
3
Filling Problem
3
3
High Test Results
3
3
Insufficient Flow or Under Infusion
3
3
Component Missing
3
3
Structural Problem
3
3
Expulsion
3
3
Improper Flow or Infusion
3
3
Failure to Shut Off
3
3
Misassembly by Users
3
3
Problem with Software Installation
2
2
Connection Problem
2
2
Material Protrusion/Extrusion
2
2
Device Contamination with Chemical or Other Material
2
2
Free or Unrestricted Flow
2
2
Inadequate User Interface
2
2
Installation-Related Problem
2
2
Chemical Spillage
2
2
Defective Device
2
2
Patient-Device Incompatibility
2
2
Volume Accuracy Problem
2
2
False Reading From Device Non-Compliance
2
2
No Display/Image
2
2
Material Frayed
2
2
Fogging
2
2
Fracture
2
2
Excess Flow or Over-Infusion
2
2
No Audible Alarm
2
2
Thermal Decomposition of Device
2
2
Device Inoperable
2
2
Difficult to Remove
2
2
Particulates
2
2
Misassembled
2
2
Misconnection
2
2
Incorrect Measurement
2
2
Mechanical Problem
2
2
Appropriate Term/Code Not Available
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
-
-