June 6, 2018 — Maquet Datascope Corp. Said it is recalling the CardioSave Hybrid Intra-aortic Balloon Pump (IABP) due to fluid ingress that may affect device operation, interrupt or delay therapy.The today that stated a design issue in the IABP can allow fluid (such as saline) to seep into the device. Adobe flash player 9.45.
The fluid can cause corrosion of internal components such as the electronic circuit boards. The FDA said this can lead to device malfunction like sudden stops, which can cause a delay or interruption in therapy. The FDA said device failure may result in immediate and serious adverse health consequences, including death.The recall includes CardioSave Hybrid IABP part numbers: 09-XX, 0998-UC-0800-XX and cart 09 (excluding 09-83, 0998-UC-0800-83 & 09-75). The FDA said all lots are affected by this recall.The manufacturing dates include Dec 12, 2011 through April 25, 2018.