The FDA expanded Datascope/Maquet’s voluntary worldwide field correction of certain intra-aortic balloon pumps to a class 1 recall. The field correction was announced June 20.
The affected models — CS100i, CS100 and CS300 — were manufactured between July 1, 2003 and June 16, according to the agency’s notice. The distribution period reported by the FDA, however, is substantially broader than what had been originally disclosed in Datascope’s field correction notice — March 24, 2003 to June 16 compared to March 23, 2003 and Dec. 11, 2013.
False blood detection alarm and ingress of fluid into the devices were the issues the FDA cited for the recall. A device failure “may result in immediate and serious adverse health consequences, including death,” the notice said. The CS300 model has already been associated with one patient death, which was reported to Datascope through a complaint.