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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 3
STERILMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC.(DBA MEDLINE REN
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENT SERVICE AND SAVINGS, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2021 55 55
2022 12 12
2023 30 30
2024 47 47
2025 66 66

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 90 90
Mechanical Problem 52 52
Mechanical Jam 32 32
Material Deformation 24 24
Patient Device Interaction Problem 10 10
Shipping Damage or Problem 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Deformation Due to Compressive Stress 8 8
Difficult to Open or Remove Packaging Material 7 7
Material Separation 7 7
Signal Artifact/Noise 6 6
Break 6 6
Positioning Problem 4 4
Contamination /Decontamination Problem 4 4
Device Reprocessing Problem 4 4
Electrical /Electronic Property Problem 4 4
Fracture 3 3
Entrapment of Device 2 2
Energy Output Problem 2 2
Insufficient Information 2 2
Defective Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Positioning Failure 2 2
Material Twisted/Bent 2 2
Tear, Rip or Hole in Device Packaging 2 2
Activation, Positioning or Separation Problem 1 1
Poor Quality Image 1 1
Unintended Movement 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Difficult to Remove 1 1
Stretched 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Detachment of Device or Device Component 1 1
Device Sensing Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Disconnect 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 162 162
Insufficient Information 17 17
Pericardial Effusion 11 11
Cardiac Tamponade 11 11
Cardiac Perforation 8 8
Abdominal Pain 3 3
Low Blood Pressure/ Hypotension 3 3
Asystole 2 2
Failure of Implant 1 1
Vascular Dissection 1 1
Perforation 1 1
Anemia 1 1
Atrial Fibrillation 1 1
Rupture 1 1
Foreign Body In Patient 1 1
Chest Pain 1 1
Pleural Effusion 1 1
Discomfort 1 1
Tachycardia 1 1
Cough 1 1
Loss of consciousness 1 1
Internal Organ Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield I Aug-28-2025
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-26-2025
3 Medline Industries, LP I Sep-26-2025
4 Stryker Sustainability Solutions II Jul-03-2024
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