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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Product CodeDTL
Regulation Number 870.4290
Device Class 2

MDR Year MDR Reports MDR Events
2020 53 55
2021 55 55
2022 48 48
2023 46 46
2024 452 452
2025 99 99

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 344 344
Human-Device Interface Problem 123 123
Loose or Intermittent Connection 98 98
Air/Gas in Device 57 57
Fluid/Blood Leak 38 38
Improper or Incorrect Procedure or Method 16 16
Physical Resistance/Sticking 16 16
Display or Visual Feedback Problem 16 16
Contamination /Decontamination Problem 14 14
Defective Device 10 10
Fitting Problem 7 7
Break 7 7
Gas/Air Leak 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Inflation Problem 7 7
Material Deformation 7 7
Device-Device Incompatibility 6 6
Crack 5 5
Tear, Rip or Hole in Device Packaging 5 5
Deflation Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Material Puncture/Hole 3 3
Difficult to Advance 3 3
Unsealed Device Packaging 3 3
Therapeutic or Diagnostic Output Failure 3 5
Difficult to Remove 3 3
Fracture 3 3
No Apparent Adverse Event 3 3
Detachment of Device or Device Component 3 3
Product Quality Problem 3 3
Noise, Audible 2 2
Mechanical Problem 2 2
Output Problem 2 2
Contamination 2 2
Device Difficult to Setup or Prepare 2 2
Material Separation 2 2
Failure to Seal 1 1
Corroded 1 1
Connection Problem 1 1
Blocked Connection 1 1
Positioning Failure 1 1
Backflow 1 1
Unable to Obtain Readings 1 1
Patient Device Interaction Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Positioning Problem 1 1
Separation Failure 1 1
Incomplete or Inadequate Connection 1 1
Device Contamination with Body Fluid 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 652 652
Blood Loss 28 28
Air Embolism 23 23
Insufficient Information 20 20
No Consequences Or Impact To Patient 13 13
Hemorrhage/Bleeding 10 10
No Known Impact Or Consequence To Patient 5 7
No Information 4 4
Injury 4 4
Low Blood Pressure/ Hypotension 4 4
Non specific EKG/ECG Changes 3 3
Ventricular Fibrillation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Arrhythmia 2 2
Embolism/Embolus 2 2
No Patient Involvement 2 2
Myocardial Infarction 2 2
Unspecified Infection 1 1
Death 1 1
Sepsis 1 1
Ischemic Heart Disease 1 1
Cardiac Arrest 1 1
Fluid Discharge 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II May-16-2023
2 LivaNova USA Inc. III Jul-17-2020
3 LivaNova USA Inc. II Jun-26-2020
4 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
5 Medline Industries Inc II Sep-24-2021
6 Merit Medical Systems, Inc. II Sep-11-2025
7 Merit Medical Systems, Inc. II Apr-11-2022
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