LIVN - FDA labels recall of blood bypass pump systems by LivaNova as most serious
- The U.S. Food and Drug Administration (FDA) on Friday classified the recall of several hundred blood bypass pump systems by LivaNova ( NASDAQ: LIVN ) as the most serious type.
- LivaNova ( LIVN ) in July recalled 484 LifeSPARC Systems in the U.S. distributed between Dec. 2019 to present.
- The LifeSPARC system is used to pump blood through a circuit outside of the body for periods lasting less than 6 hours in cardiopulmonary or circulatory bypass procedures.
- LIVN initiated the recall due to a possible software malfunction in a controller which is part of the system. The malfunction could lead to the device entering critical failure mode.
- The FDA on Friday classified the recall as a Class I recall , the most serious type as per its rules.
- LIVN said there have been 66 complaints regarding the issue, while the FDA has received reports of two injuries and no deaths.
- LivaNova ( LIVN ) stock +8.4% to $52.45 amid modest gains in broader U.S. markets.
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FDA labels recall of blood bypass pump systems by LivaNova as most serious