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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 53
2021 55 55
2022 48 48
2023 46 46
2024 453 453
2025 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 330 330
Human-Device Interface Problem 123 123
Loose or Intermittent Connection 78 78
Air/Gas in Device 57 57
Fluid/Blood Leak 29 29
Improper or Incorrect Procedure or Method 16 16
Display or Visual Feedback Problem 16 16
Physical Resistance/Sticking 15 15
Defective Device 8 8
Fitting Problem 7 7
Material Deformation 7 7
Gas/Air Leak 7 7
Break 6 6
Inflation Problem 6 6
Device-Device Incompatibility 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Device Contamination with Chemical or Other Material 4 4
Tear, Rip or Hole in Device Packaging 4 4
Contamination /Decontamination Problem 4 4
No Apparent Adverse Event 3 3
Product Quality Problem 3 3
Difficult to Remove 3 3
Deflation Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Unsealed Device Packaging 3 3
Difficult to Advance 3 3
Crack 3 3
Device Difficult to Setup or Prepare 2 2
Contamination 2 2
Material Separation 2 2
Detachment of Device or Device Component 2 2
Material Puncture/Hole 2 2
Fracture 2 2
Mechanical Problem 2 2
Unstable 2 2
Noise, Audible 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Patient Device Interaction Problem 1 1
Unable to Obtain Readings 1 1
Backflow 1 1
Separation Failure 1 1
Connection Problem 1 1
Device Contamination with Body Fluid 1 1
Corroded 1 1
Material Split, Cut or Torn 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 605 605
Blood Loss 28 28
Air Embolism 19 19
Insufficient Information 17 17
No Consequences Or Impact To Patient 13 13
Hemorrhage/Bleeding 10 10
No Known Impact Or Consequence To Patient 5 5
No Information 4 4
Injury 4 4
Ventricular Fibrillation 3 3
Low Blood Pressure/ Hypotension 3 3
Non specific EKG/ECG Changes 2 2
No Patient Involvement 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arrhythmia 1 1
Death 1 1
Myocardial Infarction 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 Apr-11-2022
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