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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
2026 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 103 103
Mechanical Problem 59 59
Mechanical Jam 34 34
Material Deformation 25 25
Adverse Event Without Identified Device or Use Problem 10 10
Device Damaged Prior to Receipt by User 10 10
Deformation Due to Compressive Stress 10 10
Patient Device Interaction Problem 9 9
Difficult to Open or Remove Packaging Material 7 7
Contamination /Decontamination Problem 7 7
Material Separation 7 7
Signal Artifact/Noise 5 5
Break 4 4
Device Reprocessing Problem 4 4
Electrical /Electronic Property Problem 4 4
Packaging Problem 3 3
Fracture 3 3
Entrapment of Device 2 2
Energy Output Problem 2 2
Positioning Problem 2 2
Material Twisted/Bent 2 2
Insufficient Device Problem Information 2 2
Delivered as Unsterile Product 2 2
Tear, Rip or Hole in Device Packaging 2 2
Physical Resistance/Sticking 1 1
Poor Quality Image 1 1
Unintended Movement 1 1
Material Integrity Problem 1 1
Difficult to Remove 1 1
Stretched 1 1
Positioning Failure 1 1
Device Handling Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Detachment of Device or Device Component 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 185 185
Insufficient Information 18 18
Pericardial Effusion 12 12
Cardiac Tamponade 11 11
Cardiac Perforation 9 9
Low Blood Pressure/ Hypotension 4 4
Abdominal Pain 3 3
Asystole 2 2
Intraoperative Cardiac Injury 1 1
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
Unspecified Tissue Injury 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 Jul-02-2026
4 Medline Industries, LP I Feb-06-2026
5 Medline Industries, LP I Sep-26-2025
6 Stryker Sustainability Solutions II May-13-2026
7 Stryker Sustainability Solutions II Jul-03-2024
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