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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
4
HAEMONETICS CORP.
SUBSTANTIALLY EQUIVALENT
3
HAEMONETICS CORPORATION
SUBSTANTIALLY EQUIVALENT
3
INARI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
INARI MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
INQUIS MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC PERFUSION SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
PROCELL SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SISU GLOBAL HEALTH
SUBSTANTIALLY EQUIVALENT
1
SORIN GROUP DEUTSCHLAND GMBH
SUBSTANTIALLY EQUIVALENT
1
SORIN GROUP ITALIA S.R.L
SUBSTANTIALLY EQUIVALENT
1
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
5
TELEFLEX MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
TLELFLEX MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
90
90
2015
87
87
2016
73
73
2017
88
88
2018
87
87
2019
64
64
2020
108
108
2021
73
73
2022
65
65
2023
39
39
2024
59
59
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
124
124
Crack
92
92
Leak/Splash
50
50
Infusion or Flow Problem
40
40
Device Operates Differently Than Expected
39
39
Insufficient Information
35
35
Suction Problem
34
34
Break
33
33
Material Integrity Problem
31
31
Mechanical Problem
30
30
Adverse Event Without Identified Device or Use Problem
30
30
Nonstandard Device
25
25
Disconnection
23
23
Air Leak
18
18
Obstruction of Flow
16
16
Device Misassembled During Manufacturing /Shipping
15
15
Improper or Incorrect Procedure or Method
14
14
Deformation Due to Compressive Stress
13
13
Noise, Audible
13
13
Material Deformation
13
13
Coagulation in Device or Device Ingredient
12
12
Gas/Air Leak
12
12
Other (for use when an appropriate device code cannot be identified)
11
11
Device Displays Incorrect Message
10
10
Difficult to Remove
9
9
Material Puncture/Hole
9
9
Device Alarm System
9
9
Optical Problem
9
9
Appropriate Term/Code Not Available
9
9
Detachment Of Device Component
9
9
Decrease in Pressure
8
8
Component Missing
8
8
Defective Component
8
8
Connection Problem
8
8
Electrical /Electronic Property Problem
7
7
Thermal Decomposition of Device
6
6
Device Inoperable
6
6
Use of Device Problem
5
5
Kinked
5
5
Contamination /Decontamination Problem
5
5
Smoking
5
5
No Apparent Adverse Event
5
5
Tear, Rip or Hole in Device Packaging
5
5
Detachment of Device or Device Component
5
5
Loose or Intermittent Connection
5
5
Device Contamination with Body Fluid
5
5
Material Twisted/Bent
4
4
Overfill
4
4
Unsealed Device Packaging
4
4
Disassembly
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
184
184
No Known Impact Or Consequence To Patient
182
182
No Consequences Or Impact To Patient
141
141
No Information
64
64
No Patient Involvement
48
48
Hemorrhage/Bleeding
45
45
Blood Loss
30
30
Pneumothorax
25
25
No Code Available
19
19
Death
16
16
Insufficient Information
15
15
Device Embedded In Tissue or Plaque
12
12
Unspecified Blood or Lymphatic problem
12
12
Cardiac Arrest
6
6
Foreign Body In Patient
6
6
Hypovolemia
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Complaint, Ill-Defined
4
4
Hemolysis
4
4
Low Blood Pressure/ Hypotension
4
4
Therapeutic Response, Decreased
4
4
Pleural Effusion
4
4
Low Oxygen Saturation
3
3
Not Applicable
3
3
Pain
3
3
Pulmonary Embolism
2
2
Respiratory Distress
2
2
Sepsis
2
2
Reaction
2
2
Hematoma
2
2
Other (for use when an appropriate patient code cannot be identified)
2
2
Low Cardiac Output
2
2
Dyspnea
2
2
Thrombosis/Thrombus
2
2
Exposure to Body Fluids
2
2
Renal Failure
1
1
Sudden Cardiac Death
1
1
Cough
1
1
Hypoxia
1
1
Skin Tears
1
1
Ruptured Aneurysm
1
1
Unspecified Heart Problem
1
1
Therapeutic Effects, Unexpected
1
1
Extubate
1
1
Loss of consciousness
1
1
Lead(s), Burn(s) From
1
1
Hemothorax
1
1
Thrombus
1
1
Aspiration Pneumonitis
1
1
Pulmonary Edema
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
Atrium Medical Corporation
II
Jul-01-2014
6
Atrium Medical Corporation
II
Jan-14-2014
7
Fenwal Inc
II
Apr-23-2019
8
Fenwal Inc
II
Mar-26-2019
9
Fresenius Kabi, LLC
II
Nov-10-2010
10
Haemonetics Corporation
II
Jan-29-2020
11
Haemonetics Corporation
II
Jan-28-2019
12
Haemonetics Corporation
II
Aug-30-2018
13
Haemonetics Corporation
II
Aug-05-2011
14
Haemonetics Corporation
II
Jun-07-2011
15
Haemonetics Corporation
II
Feb-22-2011
16
Maquet Cardiovascular, LLC
I
Jan-12-2024
17
Medtronic Perfusion Systems
II
Jan-29-2019
18
Stryker Instruments Div. of Stryker Corporation
II
May-01-2015
19
Stryker Instruments Div. of Stryker Corporation
II
Jan-29-2010
20
Teleflex Medical
II
Apr-28-2016
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