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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
137
137
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
137
137
Fluid/Blood Leak
122
122
Leak/Splash
110
110
Disconnection
110
110
Break
72
72
Incorrect, Inadequate or Imprecise Result or Readings
69
69
Detachment Of Device Component
49
49
Separation Failure
29
29
Separation Problem
23
23
Detachment of Device or Device Component
23
23
Air Leak
14
14
Crack
14
14
Pressure Problem
13
13
Incorrect Measurement
13
13
Unable to Obtain Readings
13
13
Device Contamination with Chemical or Other Material
12
12
Inaccurate Information
12
12
Air/Gas in Device
11
11
No Flow
10
10
Connection Problem
10
10
High Readings
10
10
Device Operates Differently Than Expected
9
9
Failure to Reset
8
8
Particulates
8
8
Output Problem
8
8
Infusion or Flow Problem
7
7
Loss of or Failure to Bond
7
7
Device Issue
7
7
Backflow
6
6
Mechanical Problem
6
6
Material Split, Cut or Torn
6
6
Loose or Intermittent Connection
6
6
Display or Visual Feedback Problem
6
6
Failure to Zero
5
5
Device Markings/Labelling Problem
5
5
Reflux within Device
5
5
Device Sensing Problem
5
5
Difficult to Insert
4
4
Material Integrity Problem
4
4
Device Displays Incorrect Message
4
4
Improper Flow or Infusion
3
3
Inappropriate Waveform
3
3
Difficult to Flush
3
3
Obstruction of Flow
3
3
Defective Device
3
3
Device Misassembled During Manufacturing /Shipping
3
3
Failure to Calibrate
3
3
Contamination
3
3
Device Inoperable
3
3
No Device Output
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
439
439
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
23
23
Hemorrhage/Bleeding
21
21
No Information
14
14
Death
6
6
Not Applicable
3
3
Exposure to Body Fluids
3
3
Low Blood Pressure/ Hypotension
3
3
Cardiac Arrest
2
2
Discomfort
2
2
Patient Problem/Medical Problem
1
1
Air Embolism
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Stroke/CVA
1
1
Complaint, Ill-Defined
1
1
Pneumothorax
1
1
Respiratory Distress
1
1
Edema
1
1
Anemia
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Burn(s)
1
1
Thrombosis
1
1
Extravasation
1
1
Extubate
1
1
Respiratory Insufficiency
1
1
Atrial Flutter
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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