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TPLC
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Device
system, hypothermia, intravenous, cooling
Product Code
NCX
Regulation Number
870.5900
Device Class
2
Premarket Reviews
Manufacturer
Decision
ZOLL CIRCULATION, INC
SE - WITH LIMITATIONS
1
1. K213031
Solex 7 Intravascular Heat Exchange Catheter, Cool
...
2. K223746
Solex 7 Intravascular Heat Exchange Catheter, Cool
...
ZOLL CIRCULATION, INC.
SE - WITH LIMITATIONS
2
1. K213031
Solex 7 Intravascular Heat Exchange Catheter, Cool
...
2. K223746
Solex 7 Intravascular Heat Exchange Catheter, Cool
...
MDR Year
MDR Reports
MDR Events
2019
438
438
2020
415
415
2021
461
461
2022
511
511
2023
373
373
2024
84
84
Device Problems
MDRs with this Device Problem
Events in those MDRs
Visual Prompts will not Clear
1055
1055
Fluid/Blood Leak
551
551
Material Integrity Problem
543
543
Use of Device Problem
304
304
Adverse Event Without Identified Device or Use Problem
63
63
Temperature Problem
47
47
Unexpected Shutdown
44
44
Insufficient Cooling
43
43
Failure to Power Up
41
41
Difficult to Remove
25
25
Insufficient Heating
25
25
Difficult to Advance
22
22
Noise, Audible
19
19
No Display/Image
18
18
Power Problem
17
17
Intermittent Loss of Power
13
13
Mechanical Problem
11
11
Unraveled Material
10
10
Leak/Splash
8
8
Display or Visual Feedback Problem
7
7
Complete Loss of Power
7
7
Detachment of Device or Device Component
6
6
Infusion or Flow Problem
5
5
Difficult to Insert
5
5
Difficult to Flush
5
5
Material Rupture
5
5
Display Difficult to Read
4
4
Backflow
4
4
Break
4
4
Material Split, Cut or Torn
4
4
Output Problem
3
3
Gas/Air Leak
3
3
Retraction Problem
3
3
Material Puncture/Hole
2
2
No Audible Prompt/Feedback
2
2
Defective Component
2
2
Crack
2
2
Improper Flow or Infusion
2
2
Excessive Cooling
2
2
Positioning Problem
2
2
Material Twisted/Bent
2
2
Appropriate Term/Code Not Available
2
2
Air/Gas in Device
2
2
Physical Resistance/Sticking
1
1
Excessive Heating
1
1
Incomplete or Inadequate Connection
1
1
Failure to Deflate
1
1
Material Protrusion/Extrusion
1
1
Therapeutic or Diagnostic Output Failure
1
1
Electrical Shorting
1
1
Unintended Power Up
1
1
Collapse
1
1
Device Alarm System
1
1
No Audible Alarm
1
1
Electrical /Electronic Property Problem
1
1
Inaccurate Flow Rate
1
1
Tear, Rip or Hole in Device Packaging
1
1
Failure to Advance
1
1
Defective Device
1
1
Device Displays Incorrect Message
1
1
Sparking
1
1
Malposition of Device
1
1
Connection Problem
1
1
Loss of Power
1
1
Material Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1054
1054
No Consequences Or Impact To Patient
451
451
Insufficient Information
429
429
No Patient Involvement
163
163
No Known Impact Or Consequence To Patient
75
75
Thrombosis/Thrombus
28
28
Cardiac Arrest
13
13
Pulmonary Embolism
9
9
Hemorrhage/Bleeding
9
9
Injury
9
9
Swelling/ Edema
9
9
Thrombus
6
6
Hematoma
5
5
Pneumothorax
5
5
Thrombosis
4
4
Infiltration into Tissue
4
4
Death
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Vessel Or Plaque, Device Embedded In
3
3
Fever
2
2
Abdominal Pain
2
2
Hemothorax
2
2
Obstruction/Occlusion
2
2
Cardiac Tamponade
2
2
Unspecified Blood or Lymphatic problem
2
2
Heart Block
1
1
Blister
1
1
No Code Available
1
1
Convulsion/Seizure
1
1
Foreign Body In Patient
1
1
Sudden Cardiac Death
1
1
Chemical Exposure
1
1
Blood Loss
1
1
Loss of consciousness
1
1
Brain Injury
1
1
Ventricular Fibrillation
1
1
Perforation of Vessels
1
1
Sepsis
1
1
Shock
1
1
Skin Discoloration
1
1
Hypothermia
1
1
Failure of Implant
1
1
Inflammation
1
1
Myocardial Infarction
1
1
Pain
1
1
Abrasion
1
1
Air Embolism
1
1
Bradycardia
1
1
Ecchymosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ZOLL Circulation, Inc.
II
Oct-06-2021
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