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TPLC
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Device
apparatus, autotransfusion
Regulation Description
Autotransfusion apparatus.
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
1
HAEMONETICS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
INARI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
1. K221483
FlowSaver Blood Return System
2. K231782
FlowSaver Blood Return System (80-101)
INARI MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
1. K221483
FlowSaver Blood Return System
2. K231782
FlowSaver Blood Return System (80-101)
INQUIS MEDICAL
SUBSTANTIALLY EQUIVALENT
1
PROCELL SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SISU GLOBAL HEALTH
SUBSTANTIALLY EQUIVALENT
1
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2020
108
108
2021
73
73
2022
65
65
2023
39
39
2024
132
140
2025
17
37
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
138
138
Crack
85
85
Mechanical Problem
44
44
Material Integrity Problem
29
29
Obstruction of Flow
19
19
Insufficient Information
17
17
Optical Problem
16
16
Electrical /Electronic Property Problem
16
16
Material Deformation
15
15
Nonstandard Device
15
15
Device Misassembled During Manufacturing /Shipping
15
15
Adverse Event Without Identified Device or Use Problem
15
15
Device Alarm System
14
14
Leak/Splash
10
10
Noise, Audible
10
10
Material Puncture/Hole
7
7
Gas/Air Leak
6
6
Suction Problem
5
5
Air/Gas in Device
5
5
Appropriate Term/Code Not Available
5
5
Material Twisted/Bent
4
4
Smoking
4
4
Improper or Incorrect Procedure or Method
4
4
Contamination /Decontamination Problem
3
3
Infusion or Flow Problem
3
3
Therapeutic or Diagnostic Output Failure
3
3
Material Discolored
3
3
Delivered as Unsterile Product
3
3
No Apparent Adverse Event
3
3
Disconnection
3
3
Break
3
3
Connection Problem
3
3
Defective Device
3
3
Detachment of Device or Device Component
3
31
Fracture
2
2
Loose or Intermittent Connection
2
2
Contamination
2
2
Use of Device Problem
2
2
Burst Container or Vessel
2
2
Free or Unrestricted Flow
1
1
Device Contamination with Body Fluid
1
1
Microbial Contamination of Device
1
1
Unsealed Device Packaging
1
1
Device Markings/Labelling Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Calibration Problem
1
1
Material Separation
1
1
Sharp Edges
1
1
Inadequacy of Device Shape and/or Size
1
1
Increase in Suction
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
250
278
Hemorrhage/Bleeding
81
81
No Known Impact Or Consequence To Patient
41
41
Insufficient Information
15
15
No Consequences Or Impact To Patient
14
14
Unspecified Blood or Lymphatic problem
12
12
No Patient Involvement
11
11
No Information
6
6
Blood Loss
6
6
Hypovolemia
5
5
Death
5
5
Pneumothorax
3
3
Low Blood Pressure/ Hypotension
3
3
Hemolysis
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Low Cardiac Output
2
2
Bradycardia
2
2
Respiratory Distress
2
2
Thrombosis/Thrombus
2
2
Pleural Effusion
2
2
Local Reaction
1
1
Anemia
1
1
Renal Failure
1
1
Unspecified Infection
1
1
Low Oxygen Saturation
1
1
Sudden Cardiac Death
1
1
Pulmonary Embolism
1
1
Blister
1
1
Skin Tears
1
1
Air Embolism
1
1
Inflammation
1
1
Ruptured Aneurysm
1
1
Unspecified Heart Problem
1
1
Cognitive Changes
1
1
Cardiac Arrest
1
1
Cough
1
1
Hemothorax
1
1
Aspiration Pneumonitis
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
Haemonetics Corporation
II
Jan-29-2020
5
Maquet Cardiovascular, LLC
I
Jan-12-2024
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