FDA Issues Class I Recall of Maquet Datascope CARDIOSAVE Hybrid IABPs

June 06, 2018

The US Food and Drug Administration (FDA) has issued a class I recall of all CARDIOSAVE Hybrid (Maquet Datascope) intra-aortic balloon pumps (IABP) manufactured since December 12, 2011, and distributed through April 2018.

The agency cites "a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction."

Maquet Datascope will contact affected customers to schedule field service by its service representatives and is expected to make a correction available by late June, according to the FDA announcement.

In the meantime, the company instructs users to "never place fluids on top of the unit; ensure that the saline container and tubing do not hang directly over the IABP" and clean and have the unit serviced, in the event of accidental spillage on the system.

The problem described by the FDA appears similar to issues with the company's CS100i, CS100, and CS300 series of IABP systems, which led to a class I recall in 2017.

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