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TPLC
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Device
catheter, septostomy
Regulation Description
Septostomy catheter.
Product Code
DXF
Regulation Number
870.5175
Device Class
2
Premarket Reviews
Manufacturer
Decision
ATRAVERSE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
BAYLIS MEDICAL COMPANY
SUBSTANTIALLY EQUIVALENT
1
CIRCA SCIENTIFIC, INC.
SUBSTANTIALLY EQUIVALENT
2
CROSS VASCULAR INC.
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
NUMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
55
55
2021
39
39
2022
70
70
2023
288
288
2024
368
368
2025
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
430
430
Failure to Advance
99
99
Difficult to Advance
85
85
Display or Visual Feedback Problem
62
62
Positioning Problem
54
54
Material Integrity Problem
50
50
Material Deformation
41
41
Detachment of Device or Device Component
25
25
Use of Device Problem
24
24
Physical Resistance/Sticking
21
21
Device-Device Incompatibility
17
17
Insufficient Information
14
14
Burst Container or Vessel
14
14
Defective Device
11
11
Difficult to Remove
10
10
Material Frayed
10
10
Device Dislodged or Dislocated
8
8
Thermal Decomposition of Device
8
8
Contamination
6
6
Packaging Problem
5
5
Unsealed Device Packaging
4
4
Device Displays Incorrect Message
4
4
Deformation Due to Compressive Stress
4
4
Material Rupture
4
4
Break
4
4
Difficult to Insert
4
4
Device Contaminated During Manufacture or Shipping
3
3
Obstruction of Flow
3
3
Tear, Rip or Hole in Device Packaging
3
3
Leak/Splash
3
3
Device Markings/Labelling Problem
2
2
Failure to Deliver Energy
2
2
Difficult or Delayed Positioning
2
2
Device Contamination with Chemical or Other Material
2
2
High impedance
2
2
Fracture
2
2
Unintended Movement
2
2
Positioning Failure
2
2
Material Puncture/Hole
1
1
Improper or Incorrect Procedure or Method
1
1
Mechanics Altered
1
1
Off-Label Use
1
1
Activation, Positioning or Separation Problem
1
1
Failure to Fire
1
1
Output below Specifications
1
1
Patient-Device Incompatibility
1
1
No Apparent Adverse Event
1
1
Communication or Transmission Problem
1
1
Entrapment of Device
1
1
Difficult to Open or Close
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pericardial Effusion
386
386
No Clinical Signs, Symptoms or Conditions
226
226
Low Blood Pressure/ Hypotension
176
176
Cardiac Tamponade
171
171
Cardiac Perforation
123
123
Thrombosis/Thrombus
57
57
Perforation of Vessels
42
42
Perforation
34
34
Hematoma
31
31
Cardiac Arrest
28
28
Hemorrhage/Bleeding
23
23
Arrhythmia
14
14
Stroke/CVA
13
13
Bradycardia
12
12
Tachycardia
12
12
Air Embolism
11
11
No Consequences Or Impact To Patient
10
10
Chest Pain
9
9
Asystole
8
8
Hemothorax
6
6
Non specific EKG/ECG Changes
6
6
Dyspnea
6
6
Insufficient Information
5
5
High Blood Pressure/ Hypertension
5
5
Foreign Body In Patient
5
5
Vascular Dissection
5
5
Fistula
5
5
Heart Block
5
5
Atrial Fibrillation
5
5
Death
4
4
Ventricular Fibrillation
4
4
Pleural Effusion
4
4
Pseudoaneurysm
4
4
Respiratory Arrest
4
4
Embolism/Embolus
4
4
Hypoxia
3
3
Transient Ischemic Attack
3
3
Intracranial Hemorrhage
3
3
Burn(s)
3
3
Diminished Pulse Pressure
2
2
Pain
2
2
Swelling/ Edema
2
2
Ischemia
2
2
Shock
2
2
Electric Shock
2
2
Thromboembolism
2
2
Needle Stick/Puncture
2
2
Diaphoresis
2
2
Loss of consciousness
2
2
Hemoptysis
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Vascular
I
Oct-16-2020
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