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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
  1.  K241224  Medline ReNewal Reprocessed Biosense Webster Webst ...
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
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 91 91
Mechanical Problem 53 53
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
Electrical /Electronic Property Problem 4 4
Device Reprocessing Problem 4 4
Positioning Problem 4 4
Contamination /Decontamination Problem 4 4
Fracture 3 3
Tear, Rip or Hole in Device Packaging 2 2
Material Twisted/Bent 2 2
Positioning Failure 2 2
Therapeutic or Diagnostic Output Failure 2 2
Defective Device 2 2
Insufficient Information 2 2
Energy Output Problem 2 2
Entrapment of Device 2 2
Stretched 1 1
Difficult to Remove 1 1
Material Integrity Problem 1 1
Defective Component 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Unintended Movement 1 1
Detachment of Device or Device Component 1 1
Device Sensing Problem 1 1
Poor Quality Image 1 1
Output Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Disconnect 1 1
Activation, Positioning or Separation Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 163 163
Insufficient Information 17 17
Pericardial Effusion 12 12
Cardiac Tamponade 11 11
Cardiac Perforation 8 8
Low Blood Pressure/ Hypotension 4 4
Abdominal Pain 3 3
Asystole 2 2
Failure of Implant 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
Pleural Effusion 1 1
Cough 1 1
Tachycardia 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 Feb-06-2026
4 Medline Industries, LP I Sep-26-2025
5 Stryker Sustainability Solutions II Jul-03-2024
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