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TPLC
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show TPLC since
2009
2010
2011
2012
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2014
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2016
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2018
2019
2020
2021
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2023
2024
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Device
cable, electrode
Product Code
IKD
Regulation Number
890.1175
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
3
3
2016
57
57
2017
33
33
2018
5
5
2019
4
4
2020
7
7
2021
11
11
2022
17
17
2023
5
5
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Connection Problem
57
57
Incorrect, Inadequate or Imprecise Result or Readings
13
13
Break
12
12
Device Operates Differently Than Expected
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Overheating of Device
4
4
Pacing Problem
3
3
Disconnection
3
3
Mechanical Problem
3
3
Melted
3
3
Insufficient Information
3
3
Communication or Transmission Problem
3
3
Failure to Conduct
2
2
Device Displays Incorrect Message
2
2
Detachment of Device or Device Component
2
2
Failure to Deliver Energy
2
2
False Positive Result
2
2
Thermal Decomposition of Device
2
2
Misconnection
2
2
Defibrillation/Stimulation Problem
2
2
Use of Device Problem
2
2
Defective Component
1
1
Invalid Sensing
1
1
Device Issue
1
1
High Readings
1
1
Low Readings
1
1
High Sensing Threshold
1
1
Low Sensing Threshold
1
1
Defective Device
1
1
Nonstandard Device
1
1
Material Separation
1
1
Peeled/Delaminated
1
1
Product Quality Problem
1
1
Failure to Capture
1
1
Circuit Failure
1
1
Device Reprocessing Problem
1
1
Material Disintegration
1
1
Erratic or Intermittent Display
1
1
No Display/Image
1
1
Electrical /Electronic Property Problem
1
1
Fire
1
1
Fracture
1
1
Labelling, Instructions for Use or Training Problem
1
1
Loose or Intermittent Connection
1
1
Misassembled
1
1
Device Alarm System
1
1
Signal Artifact/Noise
1
1
Bent
1
1
Device Contamination with Chemical or Other Material
1
1
Gas/Air Leak
1
1
Capturing Problem
1
1
No Pacing
1
1
Material Split, Cut or Torn
1
1
Output Problem
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
87
87
No Clinical Signs, Symptoms or Conditions
29
29
No Consequences Or Impact To Patient
7
7
Insufficient Information
4
4
No Patient Involvement
3
3
Arrhythmia
3
3
Cardiac Arrest
2
2
Complete Heart Block
2
2
Not Applicable
1
1
No Information
1
1
No Code Available
1
1
Limb Fracture
1
1
Death
1
1
Fainting
1
1
Hypoxia
1
1
Pain
1
1
Scarring
1
1
Skin Irritation
1
1
Burn(s)
1
1
Cardiac Perforation
1
1
Diminished Pulse Pressure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ad-Tech Medical Instrument Corporation
II
Sep-20-2021
2
Ad-Tech Medical Instrument Corporation
II
Apr-15-2016
3
GE Healthcare, LLC
III
Mar-26-2019
4
Oscor, Inc.
I
Apr-10-2017
5
St. Jude Medical
II
Aug-05-2011
6
Sterilmed Inc
II
Jan-13-2009
7
Vermed, Inc.
II
May-04-2011
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