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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
2021 55 55
2022 48 48
2023 46 46
2024 452 452
2025 113 113
2026 64 64

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 330 330
Loose or Intermittent Connection 137 137
Human-Device Interface Problem 123 123
Air/Gas in Device 59 59
Fluid/Blood Leak 36 36
Improper or Incorrect Procedure or Method 16 16
Display or Visual Feedback Problem 16 16
Contamination /Decontamination Problem 15 15
Physical Resistance/Sticking 14 14
Unstable 12 12
Defective Device 10 10
Connection Problem 9 9
Fitting Problem 7 7
Break 7 7
Crack 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
Tear, Rip or Hole in Device Packaging 5 5
Material Puncture/Hole 3 3
Deflation Problem 3 3
Fracture 3 3
No Apparent Adverse Event 3 3
Device Difficult to Setup or Prepare 3 3
Detachment of Device or Device Component 3 3
Gas/Air Leak 3 3
Product Quality Problem 3 3
Material Separation 3 3
Noise, Audible 2 2
Material Split, Cut or Torn 2 2
Mechanical Problem 2 2
Output Problem 2 2
Incomplete or Inadequate Connection 2 2
Difficult to Advance 2 2
Unsealed Device Packaging 2 2
Contamination 2 2
Device Contamination with Chemical or Other Material 2 2
Failure to Seal 1 1
Corroded 1 1
Blocked Connection 1 1
Component Missing 1 1
Positioning Failure 1 1
Unable to Obtain Readings 1 1
Patient Device Interaction Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Difficult to Remove 1 1
Therapeutic or Diagnostic Output Failure 1 1
Positioning Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 719 719
Insufficient Information 24 24
Air Embolism 23 23
Hemorrhage/Bleeding 11 11
Low Blood Pressure/ Hypotension 5 5
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
Myocardial Infarction 2 2
No Consequences Or Impact To Patient 2 2
Unspecified Infection 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 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
3 Medline Industries Inc II Sep-24-2021
4 Medline Industries, LP I May-08-2026
5 Medline Industries, LP I Apr-07-2026
6 Merit Medical Systems, Inc. II Nov-17-2025
7 Merit Medical Systems, Inc. II Sep-11-2025
8 Merit Medical Systems, Inc. II Apr-11-2022
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