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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
30
30
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
120
120
Leak/Splash
110
110
Disconnection
97
97
Fluid/Blood Leak
94
94
Incorrect, Inadequate or Imprecise Result or Readings
64
64
Break
54
54
Detachment Of Device Component
49
49
Separation Failure
29
29
Separation Problem
19
19
Detachment of Device or Device Component
18
18
Air Leak
14
14
Incorrect Measurement
13
13
Unable to Obtain Readings
13
13
Pressure Problem
13
13
Device Contamination with Chemical or Other Material
12
12
Crack
12
12
Air/Gas in Device
10
10
Inaccurate Information
9
9
Connection Problem
9
9
Device Operates Differently Than Expected
9
9
High Readings
9
9
Failure to Reset
8
8
Particulates
8
8
Output Problem
8
8
No Flow
7
7
Infusion or Flow Problem
7
7
Loss of or Failure to Bond
7
7
Device Issue
7
7
Display or Visual Feedback Problem
6
6
Mechanical Problem
6
6
Loose or Intermittent Connection
6
6
Backflow
6
6
Reflux within Device
5
5
Device Sensing Problem
5
5
Device Markings/Labelling Problem
5
5
Failure to Zero
4
4
Difficult to Insert
4
4
Device Displays Incorrect Message
4
4
Defective Device
3
3
Device Inoperable
3
3
Inappropriate Waveform
3
3
Tear, Rip or Hole in Device Packaging
3
3
Obstruction of Flow
3
3
Failure to Calibrate
3
3
Contamination
3
3
Difficult to Flush
3
3
Failure to Prime
3
3
Device Misassembled During Manufacturing /Shipping
3
3
Material Integrity Problem
3
3
Improper Flow or Infusion
3
3
Material Split, Cut or Torn
3
3
Material Deformation
2
2
Calibration Problem
2
2
Gas/Air Leak
2
2
Activation, Positioning or Separation Problem
2
2
Fail-Safe Problem
2
2
Nonstandard Device
2
2
Hole In Material
2
2
Display Difficult to Read
2
2
Burst Container or Vessel
2
2
Device Alarm System
2
2
Cut In Material
2
2
Difficult to Remove
2
2
No Device Output
2
2
Overheating of Device
1
1
Failure to Analyze Signal
1
1
Material Rupture
1
1
Failure to Sense
1
1
Air eliminator, defective
1
1
Stopcock valve, failure of
1
1
Component Missing
1
1
Device Contamination with Body Fluid
1
1
Blood pooling
1
1
Failure to Select Signal
1
1
Device Slipped
1
1
Sticking
1
1
Incorrect Or Inadequate Test Results
1
1
Dull, Blunt
1
1
Structural Problem
1
1
Blocked Connection
1
1
Bent
1
1
Partial Blockage
1
1
Complete Blockage
1
1
No Display/Image
1
1
Decoupling
1
1
Deflation Problem
1
1
Fracture
1
1
Material Fragmentation
1
1
Material Frayed
1
1
False Reading From Device Non-Compliance
1
1
Melted
1
1
Migration or Expulsion of Device
1
1
Occlusion Within Device
1
1
Unintended Collision
1
1
Device Difficult to Program or Calibrate
1
1
Material Puncture/Hole
1
1
Device Packaging Compromised
1
1
Mechanical Jam
1
1
Device Contaminated During Manufacture or Shipping
1
1
Priming Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
340
340
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
16
16
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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