Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Product CodeDTL
Regulation Number 870.4290
Device Class 2


Premarket Reviews
ManufacturerDecision
COEUR, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC.
  SUBSTANTIALLY EQUIVALENT 1
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
JILIN CORONADO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNEXMED(SHENZHEN)COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS ZERUSA LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZERUSA LIMITED
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 80 80
2015 89 89
2016 67 67
2017 106 106
2018 84 84
2019 76 76
2020 53 53
2021 55 55
2022 48 48
2023 46 46
2024 73 73

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 363 363
Loose or Intermittent Connection 68 68
Hole In Material 29 29
Fluid/Blood Leak 28 28
Human-Device Interface Problem 28 28
Tear, Rip or Hole in Device Packaging 27 27
Unable to Obtain Readings 19 19
Infusion or Flow Problem 18 18
Display or Visual Feedback Problem 17 17
Air Leak 16 16
Device Contamination with Chemical or Other Material 16 16
Crack 15 15
Break 12 12
Detachment Of Device Component 11 11
Suction Problem 11 11
Device Markings/Labelling Problem 10 10
Air/Gas in Device 10 10
Physical Resistance/Sticking 9 9
Defective Device 9 9
Improper or Incorrect Procedure or Method 8 8
Device Operates Differently Than Expected 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Physical Resistance 7 7
Inflation Problem 7 7
Failure to Cycle 6 6
Delivered as Unsterile Product 6 6
Gas/Air Leak 6 6
Improper Device Output 6 6
Material Deformation 6 6
No Flow 6 6
Material Integrity Problem 5 5
Device Packaging Compromised 5 5
Difficult to Advance 5 5
Difficult to Insert 5 5
Fracture 4 4
Deflation Problem 4 4
Difficult to Remove 4 4
Use of Device Problem 4 4
Connection Problem 4 4
Device Disinfection Or Sterilization Issue 4 4
Improper Flow or Infusion 3 3
Detachment of Device or Device Component 3 3
Contamination /Decontamination Problem 3 3
Unsealed Device Packaging 3 3
Mechanical Problem 3 3
Material Puncture/Hole 3 3
Product Quality Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Apparent Adverse Event 3 3
Noise, Audible 2 2
Suction Failure 2 2
Pressure Problem 2 2
Material Split, Cut or Torn 2 2
Difficult To Position 2 2
Device Difficult to Setup or Prepare 2 2
Problem with Sterilization 2 2
Material Separation 2 2
Unstable 2 2
Component Missing 2 2
Insufficient Flow or Under Infusion 2 2
Device Contaminated During Manufacture or Shipping 2 2
Mechanical Jam 1 1
Difficult to Open or Close 1 1
Filtration Problem 1 1
Fitting Problem 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Device Damaged Prior to Use 1 1
Device Contamination with Body Fluid 1 1
Implant Mobility NOS (Not otherwise specified) 1 1
Malfunction 1 1
Obstruction of Flow 1 1
Failure to Advance 1 1
Separation Failure 1 1
Device Slipped 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Inoperable 1 1
Failure to Zero 1 1
Off-Label Use 1 1
Disconnection 1 1
Decoupling 1 1
Corroded 1 1
Bent 1 1
Backflow 1 1
Difficult to Flush 1 1
Flushing Problem 1 1
Kinked 1 1
Excess Flow or Over-Infusion 1 1
Patient Device Interaction Problem 1 1
Output Problem 1 1
Packaging Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Missing Value Reason 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 233 233
No Clinical Signs, Symptoms or Conditions 196 196
Blood Loss 115 115
No Known Impact Or Consequence To Patient 85 85
No Patient Involvement 62 62
Not Applicable 24 24
Air Embolism 23 23
No Information 18 18
Insufficient Information 17 17
Cardiac Arrest 9 9
Injury 6 6
Hemorrhage/Bleeding 4 4
Low Blood Pressure/ Hypotension 4 4
Non specific EKG/ECG Changes 2 2
Embolism 2 2
ST Segment Elevation 2 2
Bradycardia 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Collapse 1 1
Obstruction/Occlusion 1 1
Respiratory Failure 1 1
No Patient involvement 1 1
Patient Problem/Medical Problem 1 1
Thrombus 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Discomfort 1 1
Myocardial Infarction 1 1
Overdose 1 1
Perforation 1 1
Death 1 1
Arrhythmia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Jul-12-2011
2 Boston Scientific Corporation II May-16-2023
3 Cook Inc. II May-09-2018
4 Dokitz NovoSci II Nov-06-2014
5 Edwards Lifesciences Llc II Dec-07-2010
6 LivaNova USA Inc. III Jul-17-2020
7 LivaNova USA Inc. II Jun-26-2020
8 Medline Industries Inc II Sep-24-2021
9 Medtronic Perfusion Systems II Jul-10-2017
10 Merit Medical Systems, Inc. II Apr-11-2022
11 Sorin Group USA, Inc. II Oct-25-2012
12 Terumo Cardiovascular Systems Corp II Jun-23-2015
13 Terumo Cardiovascular Systems Corporation II Jun-21-2018
14 Thomas Medical Products Inc II Feb-14-2011
15 Vascular Solutions, Inc. I Apr-07-2016
16 Vascular Solutions, Inc. I Mar-20-2013
17 Vascular Solutions, Inc. II Sep-17-2012
-
-