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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 68 68

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 418 418
Loose or Intermittent Connection 145 145
Human-Device Interface Problem 123 123
Air/Gas in Device 59 59
Fluid/Blood Leak 33 33
Physical Resistance/Sticking 22 22
Improper or Incorrect Procedure or Method 19 19
Display or Visual Feedback Problem 17 17
Contamination /Decontamination Problem 15 15
Unstable 13 13
Defective Device 8 8
Connection Problem 8 8
Tear, Rip or Hole in Device Packaging 7 7
Fitting Problem 7 7
Inflation Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Material Deformation 7 7
Failure to Cycle 6 6
Difficult to Advance 6 6
Device-Device Incompatibility 6 6
Break 5 5
Crack 5 5
Deflation Problem 4 4
Product Quality Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Material Split, Cut or Torn 3 3
No Apparent Adverse Event 3 3
Gas/Air Leak 3 3
Difficult to Remove 3 3
Device Difficult to Setup or Prepare 3 3
Unsealed Device Packaging 3 3
Difficult to Insert 3 3
Fracture 3 3
Material Separation 2 2
Material Puncture/Hole 2 2
Noise, Audible 2 2
Contamination 2 2
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Blocked Connection 1 1
Damaged Thread 1 1
Incomplete or Inadequate Connection 1 1
Positioning Problem 1 1
Insufficient Device Problem Information 1 1
Patient Device Interaction Problem 1 1
Mechanical Problem 1 1
Use of Device Problem 1 1
Flushing Problem 1 1
Positioning Failure 1 1
Device Contamination with Body Fluid 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 728 728
No Consequences Or Impact To Patient 60 60
Blood Loss 42 42
Insufficient Information 25 25
Air Embolism 23 23
No Known Impact Or Consequence To Patient 14 16
Hemorrhage/Blood Loss/Bleeding 11 11
No Patient Involvement 6 6
Injury 5 5
Low Blood Pressure/ Hypotension 5 5
No Information 5 5
Non specific EKG/ECG Changes 3 3
Ventricular Fibrillation 3 3
Arrhythmia 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Embolism/Embolus 2 2
Myocardial Infarction 2 2
Sepsis 1 1
Cardiac Arrest 1 1
Death 1 1
Fluid Discharge 1 1
Ischemic Heart Disease 1 1
Unspecified Infection 1 1
Not Applicable 1 1
Overdose 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 Medline Industries, LP I May-08-2026
7 Medline Industries, LP I Apr-07-2026
8 Merit Medical Systems, Inc. II Nov-17-2025
9 Merit Medical Systems, Inc. II Sep-11-2025
10 Merit Medical Systems, Inc. II Apr-11-2022
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