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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, recording, electrode, reprocessed
Regulation Description Electrode recording catheter or electrode recording probe.
Definition Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNLH
Regulation Number 870.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
INNOVATIVE HEALTH
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 4
STERILMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC.
  SUBSTANTIALLY EQUIVALENT 4
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC.(DBA MEDLINE REN
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 28 28
2021 55 55
2022 12 12
2023 30 30
2024 47 47
2025 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 71 71
Mechanical Problem 51 51
Material Deformation 33 33
Mechanical Jam 28 28
Shipping Damage or Problem 10 10
Patient Device Interaction Problem 9 9
Inadequacy of Device Shape and/or Size 7 7
Break 7 7
Difficult to Open or Remove Packaging Material 7 7
Deformation Due to Compressive Stress 6 6
Signal Artifact/Noise 6 6
Material Separation 6 6
Device Reprocessing Problem 4 4
Entrapment of Device 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Positioning Problem 2 2
Insufficient Information 2 2
Contamination /Decontamination Problem 2 2
Defective Device 2 2
Fracture 2 2
Energy Output Problem 2 2
Positioning Failure 2 2
Electrical /Electronic Property Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Twisted/Bent 2 2
Physical Resistance/Sticking 1 1
Structural Problem 1 1
Failure to Advance 1 1
Failure to Disconnect 1 1
Stretched 1 1
Contamination 1 1
Difficult to Remove 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Device Sensing Problem 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Packaging Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 145 145
Insufficient Information 15 15
No Consequences Or Impact To Patient 13 13
Cardiac Tamponade 8 8
Pericardial Effusion 7 7
No Known Impact Or Consequence To Patient 5 5
Cardiac Perforation 5 5
Abdominal Pain 3 3
Low Blood Pressure/ Hypotension 3 3
Failure of Implant 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Vascular Dissection 1 1
Perforation 1 1
Rupture 1 1
Atrial Fibrillation 1 1
Anemia 1 1
Foreign Body In Patient 1 1
Chest Pain 1 1
Discomfort 1 1
Cough 1 1
Tachycardia 1 1
Tricuspid Regurgitation 1 1
Loss of consciousness 1 1
Internal Organ Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-26-2025
2 Stryker Sustainability Solutions II Jul-03-2024
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