Brief: FDA Says Livanova (Tandemlife) Recalls Lifesparc System For Risk Of Unintentional Extended Pump Stop During Controller Critical Failure

Livanova

30/09/2022 15:53

Sept 30 (Reuters) - FDA :
    * FDA SAYS LIVANOVA (TANDEMLIFE) RECALLS LIFESPARC SYSTEM
FOR RISK
OF UNINTENTIONAL EXTENDED PUMP STOP DURING CONTROLLER CRITICAL
FAILURE
    * FDA SAYS HAS IDENTIFIED RECALL OF LIFESPARC SYSTEM AS A
CLASS I
RECALL
    * FDA SAYS LIVANOVA (TANDEMLIFE) IS RECALLING THE LIFESPARC
CONTROLLER, PART OF THE LIFESPARC SYSTEM DUE TO A SOFTWARE
MALFUNCTION
    * FDA SAYS LIVANOVA REPORTED THERE HAVE BEEN 66 COMPLAINTS,
AND
THE FDA HAS RECEIVED TWO INJURIES AND NO DEATHS DUE TO THIS
ISSUE IN LIFESPARC SYSTEM

Further company coverage:  LIVN.O 
 ((Reuters.Briefs@thomsonreuters.com;))