Quest Medical voluntarily recalled certain lots of its Myocardial Protection System (MPS) delivery sets on Oct. 28 after finding the products had a possible seal failure that could lead to blood loss in patients.
The company said in a news release that it had received 20 complaints alleging the seal failure, which resulted in 16 patients losing blood during surgeries. No patients have been injured due to the alleged issue, according to Quest.
The recalled products were manufactured from May 2015 to September 2015 and distributed from June 2015 to September 2015.
The recall affects some lots of the MPS delivery set with arrest agent and additive cassettes, heat exchanger and 10-foot delivery tubing; the MPS delivery set with 6-foot delivery tubing; and the MPS low volume delivery set.
The MPS delivery set is intended for perfusionists and physicians to deliver whole blood and/or cardio-protective drugs and solutions to the heart during open heart surgery.