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TPLC
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Device
catheter, septostomy
Product Code
DXF
Regulation Number
870.5175
Device Class
2
Premarket Reviews
Manufacturer
Decision
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
NUMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
36
36
2019
24
24
2020
55
55
2021
39
39
2022
70
70
2023
187
187
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
259
259
Failure to Advance
28
28
Burst Container or Vessel
22
22
Difficult to Advance
15
15
Insufficient Information
15
15
Detachment of Device or Device Component
10
10
Material Deformation
8
8
Material Integrity Problem
7
7
Positioning Problem
7
7
Deflation Problem
6
6
Leak/Splash
5
5
Break
5
5
Display or Visual Feedback Problem
5
5
Device-Device Incompatibility
5
5
Material Rupture
5
5
Physical Resistance/Sticking
5
5
Packaging Problem
4
4
Use of Device Problem
4
4
Improper or Incorrect Procedure or Method
3
3
Material Separation
3
3
Deformation Due to Compressive Stress
3
3
Thermal Decomposition of Device
3
3
Difficult to Remove
3
3
Unintended Movement
2
2
Device Dislodged or Dislocated
2
2
Mechanical Problem
2
2
Material Frayed
2
2
High impedance
2
2
Positioning Failure
2
2
Material Puncture/Hole
2
2
Device Damaged Prior to Use
1
1
Component Missing
1
1
Obstruction of Flow
1
1
Communication or Transmission Problem
1
1
Activation, Positioning or Separation Problem
1
1
Defective Device
1
1
Device Displays Incorrect Message
1
1
Failure to Fire
1
1
Patient-Device Incompatibility
1
1
Inflation Problem
1
1
Difficult or Delayed Positioning
1
1
Migration or Expulsion of Device
1
1
Off-Label Use
1
1
Loose or Intermittent Connection
1
1
Contamination
1
1
Failure to Deliver Energy
1
1
Entrapment of Device
1
1
Fracture
1
1
Electromagnetic Compatibility Problem
1
1
Improper Flow or Infusion
1
1
Difficult to Open or Close
1
1
Output below Specifications
1
1
No Apparent Adverse Event
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pericardial Effusion
162
162
Cardiac Tamponade
84
84
No Clinical Signs, Symptoms or Conditions
65
65
Low Blood Pressure/ Hypotension
44
44
No Consequences Or Impact To Patient
26
26
Thrombosis/Thrombus
25
25
Cardiac Perforation
22
22
Perforation
22
22
No Known Impact Or Consequence To Patient
12
12
Perforation of Vessels
12
12
Hematoma
11
11
Stroke/CVA
8
8
Arrhythmia
7
7
Hemorrhage/Bleeding
7
7
Death
7
7
Cardiac Arrest
5
5
Foreign Body In Patient
5
5
Insufficient Information
5
5
Heart Block
4
4
Embolism/Embolus
4
4
Pseudoaneurysm
4
4
Bradycardia
4
4
Air Embolism
3
3
Chest Pain
3
3
Hemothorax
3
3
Tachycardia
3
3
Fistula
3
3
Transient Ischemic Attack
3
3
Diaphoresis
2
2
High Blood Pressure/ Hypertension
2
2
Hypoxia
2
2
Atrial Fibrillation
2
2
Dyspnea
2
2
Embolism
2
2
Intracranial Hemorrhage
2
2
Hemoptysis
2
2
Vascular Dissection
2
2
Device Embedded In Tissue or Plaque
2
2
Thromboembolism
2
2
Pericarditis
2
2
Asystole
2
2
Respiratory Arrest
2
2
Cough
1
1
Ischemia Stroke
1
1
Unspecified Vascular Problem
1
1
No Code Available
1
1
Complete Heart Block
1
1
Electric Shock
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Infarction, Cerebral
1
1
Nerve Damage
1
1
Pneumothorax
1
1
Pulmonary Valve Stenosis
1
1
Hypopyon
1
1
Hypersensitivity/Allergic reaction
1
1
Rupture
1
1
Thrombus
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Edwards Lifesciences, LLC
I
Apr-25-2019
2
Medtronic Vascular
I
Oct-16-2020
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