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TPLC
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show TPLC since
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2024
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Device
reservoir, blood, cardiopulmonary bypass
Product Code
DTN
Regulation Number
870.4400
Device Class
2
Premarket Reviews
Manufacturer
Decision
CIRCULATORY TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
GISH BIOMEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
4
MAQUET CARDIOPULMONARY AG
SUBSTANTIALLY EQUIVALENT
5
MEDTRONIC CARDIAC SURGERY
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
3
SORIN GROUP ITALIA S.R.L
SUBSTANTIALLY EQUIVALENT
2
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
4
SPECTRUM MEDICAL S.R.L.
SUBSTANTIALLY EQUIVALENT
1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
52
52
2015
25
25
2016
6
6
2017
3
3
2018
4
4
2019
10
10
2020
6
6
2021
12
13
2022
7
7
2023
8
8
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
25
25
Fluid/Blood Leak
14
14
Air/Gas in Device
13
13
Other (for use when an appropriate device code cannot be identified)
9
9
Obstruction of Flow
8
8
Infusion or Flow Problem
7
7
Gas/Air Leak
6
6
Air Leak
6
6
Break
5
5
Pressure Problem
4
4
Device Operates Differently Than Expected
4
4
Component(s), broken
3
3
Collapse
3
3
Disconnection
3
3
Detachment Of Device Component
3
3
Device Inoperable
3
3
Device Dislodged or Dislocated
3
4
Device Displays Incorrect Message
2
2
Electrical /Electronic Property Problem
2
2
Improper or Incorrect Procedure or Method
2
3
Nonstandard Device
2
2
Positioning Problem
2
2
Defective Component
2
2
Filtration Problem
2
2
Crack
2
2
Increase in Pressure
2
2
Misassembled
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Lack of Maintenance Documentation or Guidelines
1
1
Fracture
1
1
Appropriate Term/Code Not Available
1
1
Packaging Problem
1
1
Misconnection
1
1
Structural Problem
1
1
Torn Material
1
1
Excess Flow or Over-Infusion
1
1
Device Damaged Prior to Use
1
1
Device Markings/Labelling Problem
1
1
Free or Unrestricted Flow
1
1
Material Disintegration
1
1
Short Fill
1
1
Unsealed Device Packaging
1
1
Therapeutic or Diagnostic Output Failure
1
1
Detachment of Device or Device Component
1
1
Environmental Particulates
1
1
Material Integrity Problem
1
1
Defective Device
1
1
No Apparent Adverse Event
1
1
Material Fragmentation
1
1
Coagulation in Device or Device Ingredient
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
47
47
No Patient Involvement
34
34
No Clinical Signs, Symptoms or Conditions
25
26
No Consequences Or Impact To Patient
12
12
No Patient involvement
9
9
Death
4
4
Cardiac Arrest
4
4
Hemorrhage/Bleeding
4
4
No Information
2
2
Fungal Infection
1
1
Abdominal Distention
1
1
Blood Loss
1
1
Paralysis
1
1
Insufficient Information
1
1
Low Blood Pressure/ Hypotension
1
1
Low Oxygen Saturation
1
1
Thrombus
1
1
Hypovolemia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Circulatory Technology Inc
II
Mar-01-2018
2
Circulatory Technology Inc
III
Oct-07-2016
3
Circulatory Technology Inc
II
Sep-15-2016
4
Circulatory Technology Inc
II
Jun-27-2016
5
Circulatory Technology Inc
II
Apr-13-2010
6
Circulatory Technology Inc.
II
Jun-15-2021
7
Datascope Corporation
II
May-08-2018
8
Maquet Medical Systems USA
II
May-26-2023
9
Medtronic Perfusion Systems
I
Mar-17-2021
10
Medtronic Perfusion Systems
II
Feb-20-2018
11
Terumo Cardiovascular Corporation
II
Aug-04-2011
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