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TPLC
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Device
apparatus, autotransfusion
Product Code
CAC
Regulation Number
868.5830
Device Class
2
Premarket Reviews
Manufacturer
Decision
ATRIUM MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS KABI AG
SUBSTANTIALLY EQUIVALENT
3
HAEMONETICS CORPORATION
SUBSTANTIALLY EQUIVALENT
2
INARI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
INARI MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC PERFUSION SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
PROCELL SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SISU GLOBAL HEALTH
SUBSTANTIALLY EQUIVALENT
1
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
88
88
2018
87
87
2019
64
64
2020
108
108
2021
73
73
2022
65
65
2023
39
39
2024
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
82
82
Crack
80
80
Material Integrity Problem
29
29
Infusion or Flow Problem
24
24
Adverse Event Without Identified Device or Use Problem
24
24
Mechanical Problem
24
24
Leak/Splash
22
22
Insufficient Information
22
22
Suction Problem
18
18
Nonstandard Device
15
15
Break
15
15
Device Misassembled During Manufacturing /Shipping
15
15
Obstruction of Flow
13
13
Deformation Due to Compressive Stress
13
13
Gas/Air Leak
12
12
Material Deformation
11
11
Improper or Incorrect Procedure or Method
11
11
Air Leak
9
9
Material Puncture/Hole
8
8
Defective Component
8
8
Device Operates Differently Than Expected
8
8
Difficult to Remove
7
7
Electrical /Electronic Property Problem
7
7
Disconnection
6
6
Thermal Decomposition of Device
6
6
Connection Problem
6
6
Component Missing
6
6
Appropriate Term/Code Not Available
6
6
Noise, Audible
6
6
No Apparent Adverse Event
5
5
Contamination /Decontamination Problem
5
5
Tear, Rip or Hole in Device Packaging
5
5
Detachment of Device or Device Component
5
5
Device Alarm System
5
5
Coagulation in Device or Device Ingredient
5
5
Detachment Of Device Component
4
4
Unsealed Device Packaging
4
4
Loose or Intermittent Connection
4
4
Device Displays Incorrect Message
4
4
Overfill
4
4
Use of Device Problem
4
4
Material Twisted/Bent
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Difficult to Open or Close
3
3
Device Contamination with Chemical or Other Material
3
3
Physical Resistance/Sticking
3
3
Therapeutic or Diagnostic Output Failure
3
3
Vibration
3
3
Smoking
3
3
Biocompatibility
3
3
Defective Device
3
3
Kinked
3
3
Material Discolored
3
3
Excess Flow or Over-Infusion
3
3
Burst Container or Vessel
2
2
Fire
2
2
Delivered as Unsterile Product
2
2
Occlusion Within Device
2
2
Inadequate Filtration Process
2
2
Self-Activation or Keying
2
2
Device Inoperable
2
2
Insufficient Flow or Under Infusion
2
2
Optical Problem
2
2
Output Problem
1
1
Positioning Problem
1
1
Pressure Problem
1
1
Protective Measures Problem
1
1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
1
1
Temperature Problem
1
1
Mechanics Altered
1
1
No Flow
1
1
Device Packaging Compromised
1
1
No Pressure
1
1
Material Split, Cut or Torn
1
1
Sharp Edges
1
1
Device Fell
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Unclear Information
1
1
Invalid Sensing
1
1
Microbial Contamination of Device
1
1
Volume Accuracy Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Slipped
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Device Stops Intermittently
1
1
Increase in Suction
1
1
Inadequate or Insufficient Training
1
1
Out-Of-Box Failure
1
1
Device Contamination with Body Fluid
1
1
Incorrect Or Inadequate Test Results
1
1
Device Tipped Over
1
1
Blocked Connection
1
1
Device Markings/Labelling Problem
1
1
Calibration Problem
1
1
Chemical Problem
1
1
Device Emits Odor
1
1
Overheating of Device
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Reflux within Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
161
161
No Known Impact Or Consequence To Patient
104
104
No Consequences Or Impact To Patient
71
71
No Patient Involvement
47
47
No Information
33
33
Hemorrhage/Bleeding
27
27
Blood Loss
20
20
Insufficient Information
14
14
Pneumothorax
13
13
Death
13
13
Unspecified Blood or Lymphatic problem
12
12
Device Embedded In Tissue or Plaque
7
7
Cardiac Arrest
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
No Code Available
4
4
Hypovolemia
4
4
Therapeutic Response, Decreased
3
3
Hemolysis
3
3
Not Applicable
3
3
Foreign Body In Patient
3
3
Thrombosis/Thrombus
2
2
Low Oxygen Saturation
2
2
Respiratory Distress
2
2
Sepsis
2
2
Dyspnea
2
2
Pulmonary Embolism
2
2
Pleural Effusion
2
2
Low Blood Pressure/ Hypotension
2
2
Hypoxia
1
1
Unspecified Infection
1
1
Inflammation
1
1
Pain
1
1
Pneumonia
1
1
Hemothorax
1
1
Abscess
1
1
Adult Respiratory Distress Syndrome
1
1
Air Embolism
1
1
Bradycardia
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Thrombus
1
1
Transient Ischemic Attack
1
1
Injury
1
1
Impaired Healing
1
1
Reaction
1
1
Sudden Cardiac Death
1
1
Skin Tears
1
1
Cognitive Changes
1
1
Local Reaction
1
1
Aspiration Pneumonitis
1
1
Cough
1
1
Blister
1
1
Ruptured Aneurysm
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Dec-28-2023
2
Atrium Medical Corporation
II
Dec-02-2023
3
Atrium Medical Corporation
II
Nov-16-2023
4
Atrium Medical Corporation
II
Feb-15-2017
5
Fenwal Inc
II
Apr-23-2019
6
Fenwal Inc
II
Mar-26-2019
7
Haemonetics Corporation
II
Jan-29-2020
8
Haemonetics Corporation
II
Jan-28-2019
9
Haemonetics Corporation
II
Aug-30-2018
10
Maquet Cardiovascular, LLC
I
Jan-12-2024
11
Medtronic Perfusion Systems
II
Jan-29-2019
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