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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
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
6
6
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Connection Problem
59
59
Incorrect, Inadequate or Imprecise Result or Readings
13
13
Break
12
12
Adverse Event Without Identified Device or Use Problem
5
5
Device Operates Differently Than Expected
5
5
Overheating of Device
4
4
Pacing Problem
3
3
Disconnection
3
3
Mechanical Problem
3
3
Melted
3
3
Communication or Transmission Problem
3
3
Insufficient Information
3
3
Detachment of Device or Device Component
2
2
Failure to Conduct
2
2
Device Displays Incorrect Message
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
Failure to Sense
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
Capturing Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Gas/Air Leak
1
1
Device Contaminated During Manufacture or Shipping
1
1
Output Problem
1
1
No Apparent Adverse Event
1
1
No Pacing
1
1
Material Split, Cut or Torn
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
33
33
No Consequences Or Impact To Patient
7
7
Arrhythmia
4
4
Insufficient Information
4
4
No Patient Involvement
3
3
Complete Heart Block
2
2
Cardiac Arrest
2
2
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
Not Applicable
1
1
No Information
1
1
No Code Available
1
1
Limb Fracture
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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