LivaNova U recalls
LivaNova U has 5 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 30 Jan 2019. The most frequent reason is sterility.
Total recalls5since 2018
Last 12 months0reported
Class I00% of total
Ongoing0latest 30 Jan 2019
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 4 80%Class III 1 20%
Why livanova u is recalled
Product types
By year
All livanova u recalls, newest first
5 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Perfusion Pack recalled by LivaNova U | LivaNova U | Sterility | 39 states |
| Device | CLASS II | Sorin Stockert Heater-Cooler System 3T, a) recalled by LivaNova U | LivaNova U | Sterility | 44 states |
| Device | CLASS II | Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO recalled | LivaNova U | Sterility | 5 states |
| Device | CLASS II | Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO recalled | LivaNova U | Sterility | 5 states |
| Device | CLASS III | Sorin Group Smart Perfusion Pack E-Pack recalled by LivaNova U | LivaNova U | Sterility | LA |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.