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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
BAYLIS MEDICAL COMPANY INC.
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
CROSS VASCULAR INC.
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
NUMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
21
21
2016
13
13
2017
13
13
2018
36
36
2019
24
24
2020
55
55
2021
39
39
2022
70
70
2023
288
288
2024
67
67
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
360
360
Failure to Advance
54
54
Difficult to Advance
43
43
Positioning Problem
37
37
Burst Container or Vessel
23
23
Material Integrity Problem
21
21
Display or Visual Feedback Problem
19
19
Insufficient Information
17
17
Material Deformation
16
16
Detachment of Device or Device Component
15
15
Device-Device Incompatibility
11
11
Deflation Problem
9
9
Use of Device Problem
9
9
Material Rupture
8
8
Physical Resistance/Sticking
7
7
Break
6
6
Leak/Splash
5
5
Defective Device
5
5
Device Displays Incorrect Message
5
5
Packaging Problem
5
5
Device Dislodged or Dislocated
4
4
Difficult to Remove
4
4
Material Frayed
4
4
Thermal Decomposition of Device
4
4
Material Separation
3
3
Peeled/Delaminated
3
3
Improper or Incorrect Procedure or Method
3
3
Deformation Due to Compressive Stress
3
3
Device Markings/Labelling Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Unintended Movement
2
2
Mechanical Problem
2
2
Material Puncture/Hole
2
2
Detachment Of Device Component
2
2
Failure to Deliver Energy
2
2
Entrapment of Device
2
2
High impedance
2
2
Difficult or Delayed Positioning
2
2
Positioning Failure
2
2
Difficult to Insert
2
2
Partial Blockage
1
1
Loose or Intermittent Connection
1
1
Inflation Problem
1
1
Fracture
1
1
Contamination
1
1
Migration or Expulsion of Device
1
1
Unsealed Device Packaging
1
1
Off-Label Use
1
1
Device Damaged Prior to Use
1
1
Component Missing
1
1
Obstruction of Flow
1
1
Failure to Fire
1
1
Patient-Device Incompatibility
1
1
No Apparent Adverse Event
1
1
Output below Specifications
1
1
Device Operates Differently Than Expected
1
1
Communication or Transmission Problem
1
1
Activation, Positioning or Separation Problem
1
1
Electromagnetic Compatibility Problem
1
1
Improper Flow or Infusion
1
1
Difficult to Open or Close
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pericardial Effusion
241
241
Cardiac Tamponade
121
121
No Clinical Signs, Symptoms or Conditions
117
117
Low Blood Pressure/ Hypotension
84
84
Cardiac Perforation
49
49
Thrombosis/Thrombus
39
39
No Consequences Or Impact To Patient
38
38
Perforation
34
34
Perforation of Vessels
25
25
Hematoma
24
24
Hemorrhage/Bleeding
17
17
No Known Impact Or Consequence To Patient
17
17
Cardiac Arrest
16
16
Stroke/CVA
13
13
Air Embolism
10
10
Arrhythmia
9
9
Death
8
8
Pseudoaneurysm
7
7
Foreign Body In Patient
6
6
Asystole
6
6
Tachycardia
6
6
Non specific EKG/ECG Changes
6
6
Dyspnea
5
5
Bradycardia
5
5
Chest Pain
5
5
Thrombus
5
5
Transient Ischemic Attack
5
5
Insufficient Information
5
5
Respiratory Arrest
4
4
Ventricular Fibrillation
4
4
Heart Block
4
4
Embolism/Embolus
4
4
Fistula
4
4
Hemothorax
4
4
High Blood Pressure/ Hypertension
4
4
Hypoxia
3
3
Burn(s)
3
3
Thromboembolism
3
3
Ventricular Tachycardia
3
3
Pain
2
2
Shock
2
2
Electric Shock
2
2
Stenosis
2
2
Diaphoresis
2
2
Vascular Dissection
2
2
Device Embedded In Tissue or Plaque
2
2
No Code Available
2
2
Pericarditis
2
2
Atrial Fibrillation
2
2
Pulmonary Embolism
2
2
Hemoptysis
2
2
Embolism
2
2
Ischemia
2
2
Pleural Effusion
2
2
Intracranial Hemorrhage
2
2
Swelling/ Edema
2
2
Unspecified Respiratory Problem
1
1
Unspecified Vascular Problem
1
1
Hypersensitivity/Allergic reaction
1
1
Hypopyon
1
1
Hypothermia
1
1
Pneumothorax
1
1
Pulmonary Valve Stenosis
1
1
Myocardial Infarction
1
1
Nerve Damage
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Infarction, Cerebral
1
1
Cough
1
1
Ischemia Stroke
1
1
No Information
1
1
Diminished Pulse Pressure
1
1
Complete Heart Block
1
1
Needle Stick/Puncture
1
1
Respiratory Failure
1
1
Low Cardiac Output
1
1
Hematuria
1
1
Rupture
1
1
Vomiting
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baylis Medical Corp *
II
Nov-10-2016
2
Edwards Lifesciences, LLC
I
Apr-25-2019
3
Medtronic Vascular
I
Oct-16-2020
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