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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
INARI MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
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
59
59
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
162
162
Crack
88
88
Mechanical Problem
49
49
Material Integrity Problem
29
29
Optical Problem
22
22
Obstruction of Flow
20
20
Material Deformation
20
20
Electrical /Electronic Property Problem
17
17
Adverse Event Without Identified Device or Use Problem
17
17
Insufficient Information
17
17
Noise, Audible
16
16
Device Alarm System
15
15
Device Misassembled During Manufacturing /Shipping
15
15
Nonstandard Device
15
15
Leak/Splash
10
10
Material Puncture/Hole
8
8
Gas/Air Leak
6
6
Air/Gas in Device
6
6
Break
5
5
Suction Problem
5
5
Appropriate Term/Code Not Available
5
5
Smoking
4
4
Improper or Incorrect Procedure or Method
4
4
Material Twisted/Bent
4
4
Infusion or Flow Problem
3
3
Detachment of Device or Device Component
3
11
Connection Problem
3
3
Contamination /Decontamination Problem
3
3
Defective Device
3
3
Delivered as Unsterile Product
3
3
No Apparent Adverse Event
3
3
Therapeutic or Diagnostic Output Failure
3
3
Disconnection
3
3
Material Discolored
3
3
Loose or Intermittent Connection
2
2
Use of Device Problem
2
2
Material Separation
2
2
Fracture
2
2
Contamination
2
2
Burst Container or Vessel
2
2
Temperature Problem
1
1
Pressure Problem
1
1
No Pressure
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Contamination with Body Fluid
1
1
Material Split, Cut or Torn
1
1
Physical Resistance/Sticking
1
1
Sharp Edges
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Misassembled During Installation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
282
290
Hemorrhage/Bleeding
98
98
No Known Impact Or Consequence To Patient
41
41
Insufficient Information
17
17
No Consequences Or Impact To Patient
14
14
Unspecified Blood or Lymphatic problem
12
12
No Patient Involvement
11
11
Blood Loss
6
6
No Information
6
6
Death
5
5
Hypovolemia
5
5
Hemolysis
3
3
Low Blood Pressure/ Hypotension
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Pneumothorax
3
3
Low Cardiac Output
3
3
Bradycardia
2
2
Thrombosis/Thrombus
2
2
Pleural Effusion
2
2
Renal Failure
2
2
Respiratory Distress
2
2
Pulmonary Embolism
1
1
Air Embolism
1
1
Anemia
1
1
Cardiac Arrest
1
1
Myocardial Contusion
1
1
Hemothorax
1
1
Unspecified Infection
1
1
Inflammation
1
1
Blister
1
1
Ruptured Aneurysm
1
1
Unspecified Heart Problem
1
1
Aspiration Pneumonitis
1
1
Cough
1
1
Local Reaction
1
1
Post Operative Wound Infection
1
1
Low Oxygen Saturation
1
1
Sudden Cardiac Death
1
1
Skin Tears
1
1
Cognitive Changes
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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