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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device normothermic preservation system for transplantation of initially unacceptable donor lungs
Definition Preservation of donor lungs for transplantation.
Product CodePHO
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 2 3 1 3 1 0

MDR Year MDR Reports MDR Events
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Failure of Device to Self-Test 2 2
Failure to Sense 2 2
Leak/Splash 1 1
Unsealed Device Packaging 1 1
Device Alarm System 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8

Recalls
Manufacturer Recall Class Date Posted
1 XVIVO PERFUSION AB II Jun-01-2022
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