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 sucker, cardiotomy return, cardiopulmonary bypass
Product CodeDTS
Regulation Number 870.4420
Device Class 2

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2018 3 3
2019 3 3
2020 2 2
2021 11 11
2022 11 11
2023 12 12
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 11 11
Mechanical Problem 6 6
Detachment of Device or Device Component 6 6
Material Deformation 6 6
Material Separation 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Material Integrity Problem 3 3
Material Puncture/Hole 3 3
Material Protrusion/Extrusion 2 2
Detachment Of Device Component 2 2
Crack 2 2
Particulates 1 1
Off-Label Use 1 1
Entrapment of Device 1 1
Restricted Flow rate 1 1
Fluid/Blood Leak 1 1
No Apparent Adverse Event 1 1
Device Slipped 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
No Consequences Or Impact To Patient 5 5
Hemorrhage/Bleeding 2 2
Foreign Body In Patient 2 2
Pseudoaneurysm 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
Mitral Valve Insufficiency/ Regurgitation 1 1
Unspecified Tissue Injury 1 1
Perforation 1 1
Perforation of Vessels 1 1
Hypovolemia 1 1
Atrial Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 International Biophysics Corp. II Aug-19-2015
-
-