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TPLC
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Device
transducer, blood-pressure, extravascular
Product Code
DRS
Regulation Number
870.2850
Device Class
2
Premarket Reviews
Manufacturer
Decision
B. BRAUN MELSUNGEN AG
SUBSTANTIALLY EQUIVALENT
1
BIOMETRIX LTD.
SUBSTANTIALLY EQUIVALENT
1
CENTURION MEDICAL PRODUCTS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
ELCAM MEDICAL A.C.A.L
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL PTE. LTD.
SUBSTANTIALLY EQUIVALENT
1
MIRADOR BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
1
MIRADOR BIOMEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
REAVILLMED
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SMITHS MEDICAL ASD, INC.
SUBSTANTIALLY EQUIVALENT
2
TERUMO CARDIOVASCULAR SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
1
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
22
22
2015
60
60
2016
89
89
2017
92
92
2018
82
82
2019
84
84
2020
41
41
2021
93
93
2022
95
95
2023
152
152
2024
51
51
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
122
122
Leak/Splash
110
110
Disconnection
104
104
Fluid/Blood Leak
99
99
Incorrect, Inadequate or Imprecise Result or Readings
65
65
Break
56
56
Detachment Of Device Component
49
49
Separation Failure
29
29
Detachment of Device or Device Component
20
20
Separation Problem
19
19
Air Leak
14
14
Pressure Problem
13
13
Unable to Obtain Readings
13
13
Incorrect Measurement
13
13
Crack
12
12
Device Contamination with Chemical or Other Material
12
12
Air/Gas in Device
10
10
Inaccurate Information
9
9
Connection Problem
9
9
High Readings
9
9
Device Operates Differently Than Expected
9
9
Failure to Reset
8
8
Particulates
8
8
Output Problem
8
8
Device Issue
7
7
Loss of or Failure to Bond
7
7
No Flow
7
7
Infusion or Flow Problem
7
7
Backflow
6
6
Mechanical Problem
6
6
Display or Visual Feedback Problem
6
6
Loose or Intermittent Connection
6
6
Device Markings/Labelling Problem
5
5
Reflux within Device
5
5
Device Sensing Problem
5
5
Device Displays Incorrect Message
4
4
Material Split, Cut or Torn
4
4
Failure to Zero
4
4
Difficult to Insert
4
4
Defective Device
3
3
Improper Flow or Infusion
3
3
Device Misassembled During Manufacturing /Shipping
3
3
Difficult to Flush
3
3
Obstruction of Flow
3
3
Failure to Calibrate
3
3
Inappropriate Waveform
3
3
Tear, Rip or Hole in Device Packaging
3
3
Material Integrity Problem
3
3
Contamination
3
3
Device Inoperable
3
3
Failure to Prime
3
3
Burst Container or Vessel
2
2
Gas/Air Leak
2
2
Difficult to Remove
2
2
Display Difficult to Read
2
2
Fail-Safe Problem
2
2
Material Puncture/Hole
2
2
Activation, Positioning or Separation Problem
2
2
Material Deformation
2
2
Incomplete or Inadequate Connection
2
2
Hole In Material
2
2
No Device Output
2
2
Cut In Material
2
2
Nonstandard Device
2
2
Calibration Problem
2
2
Device Alarm System
2
2
Failure to Select Signal
1
1
Blood pooling
1
1
Dull, Blunt
1
1
Material Rupture
1
1
Failure to Analyze Signal
1
1
Blocked Connection
1
1
Incorrect Or Inadequate Test Results
1
1
Overheating of Device
1
1
Device Slipped
1
1
Device Packaging Compromised
1
1
Material Fragmentation
1
1
Mechanical Jam
1
1
Complete Blockage
1
1
Unintended Collision
1
1
Partial Blockage
1
1
Device Contaminated During Manufacture or Shipping
1
1
Unintended Movement
1
1
Unexpected Color
1
1
Reset Problem
1
1
Sticking
1
1
No Pressure
1
1
Deflation Problem
1
1
Component Missing
1
1
Appropriate Term/Code Not Available
1
1
No Display/Image
1
1
Structural Problem
1
1
Melted
1
1
Physical Property Issue
1
1
Stopcock valve, failure of
1
1
Device Difficult to Program or Calibrate
1
1
Air eliminator, defective
1
1
Occlusion Within Device
1
1
Explosion
1
1
Priming Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
359
359
No Consequences Or Impact To Patient
300
300
No Known Impact Or Consequence To Patient
95
95
Blood Loss
46
47
No Patient Involvement
30
30
Insufficient Information
19
19
Hemorrhage/Bleeding
18
18
No Information
14
14
Death
6
6
Exposure to Body Fluids
3
3
Low Blood Pressure/ Hypotension
3
3
Not Applicable
3
3
Discomfort
2
2
Cardiac Arrest
2
2
Stroke/CVA
1
1
Edema
1
1
Extravasation
1
1
Burn(s)
1
1
Air Embolism
1
1
Anemia
1
1
Atrial Flutter
1
1
Complaint, Ill-Defined
1
1
Extubate
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Pneumothorax
1
1
Respiratory Distress
1
1
Thrombosis
1
1
Respiratory Insufficiency
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Patient Problem/Medical Problem
1
1
Full thickness (Third Degree) Burn
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Argon Medical Devices, Inc
II
Nov-05-2019
2
Edwards Lifesciences, LLC
II
Nov-29-2023
3
Edwards Lifesciences, LLC
II
Sep-11-2013
4
ICU Medical, Inc.
II
Mar-28-2019
5
ICU Medical, Inc.
II
Nov-15-2016
6
ICU Medical, Inc.
II
Sep-15-2016
7
ICU Medical, Inc.
II
Aug-07-2014
8
Smiths Medical ASD Inc.
II
Apr-21-2021
9
Smiths Medical Asd Inc
II
Jan-17-2024
10
Utah Medical Products, Inc
II
Jun-13-2013
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