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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
2019 76 76
2020 53 55
2021 55 55
2022 48 48
2023 46 46
2024 452 452
2025 113 113
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 411 411
Human-Device Interface Problem 123 123
Loose or Intermittent Connection 118 118
Air/Gas in Device 57 57
Fluid/Blood Leak 41 41
Physical Resistance/Sticking 22 22
Improper or Incorrect Procedure or Method 19 19
Display or Visual Feedback Problem 17 17
Contamination /Decontamination Problem 16 16
Defective Device 10 10
Unstable 9 9
Gas/Air Leak 8 8
Break 7 7
Crack 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Material Deformation 7 7
Inflation Problem 7 7
Fitting Problem 7 7
Tear, Rip or Hole in Device Packaging 6 6
Device-Device Incompatibility 6 6
Failure to Cycle 6 6
Difficult to Advance 5 5
Product Quality Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Deflation Problem 4 4
Detachment of Device or Device Component 3 3
Difficult to Insert 3 3
Fracture 3 3
Unsealed Device Packaging 3 3
Material Puncture/Hole 3 3
Difficult to Remove 3 3
Therapeutic or Diagnostic Output Failure 3 5
No Apparent Adverse Event 3 3
Material Separation 2 2
Mechanical Problem 2 2
Device Difficult to Setup or Prepare 2 2
Output Problem 2 2
Noise, Audible 2 2
Material Split, Cut or Torn 2 2
Contamination 2 2
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Blocked Connection 1 1
Separation Failure 1 1
Failure to Seal 1 1
Incomplete or Inadequate Connection 1 1
Patient Device Interaction Problem 1 1
Positioning Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 680 680
No Consequences Or Impact To Patient 60 60
Blood Loss 42 42
Air Embolism 23 23
Insufficient Information 21 21
No Known Impact Or Consequence To Patient 14 16
Hemorrhage/Bleeding 11 11
No Patient Involvement 6 6
No Information 5 5
Injury 5 5
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
Unspecified Infection 1 1
Death 1 1
Not Applicable 1 1
Sepsis 1 1
Ischemic Heart Disease 1 1
Overdose 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 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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