FDA: Quest Medical recalls certain lots of Myocardial Protection System delivery sets

Editor's Note

Quest Medical, Inc (Allen, Texas), on October 28 initiated a nationwide recall of its Myocardial Protection System delivery sets, Models 5001102, 5001102-AS, and 7001102 of specified lots.

The sets have shown possible seal failure along the blood source channel of the main pump cassette, resulting in blood loss from the bypass circuit and interruption of cardioplegia solution delivery.

Quest has received 20 complaints of seal failure, which has resulted in 16 instances of patient blood loss during surgery.

Posted 10/29/2015] AUDIENCE: Risk Manager ISSUE: The identified lots of MPS Delivery sets have shown a possible seal failure along the blood source channel of main pump cassette, resulting in blood loss from the bypass circuit and interruption of cardioplegia solution delivery.