FDA Extends Datascope Field Correction to Class I Recall

The FDA expanded Datascope/Maquet’s June 20 voluntary worldwide field correction of certain intra-aortic balloon pumps and designated it a Class I recall.

The distribution period reported by the FDA is substantially broader than what had been originally disclosed in Datascope’s field correction notice — March 24, 2003 to June 16, 2017 compared to March 23, 2003 and Dec. 11, 2013.

The FDA said false blood detection alarms and ingress of fluid into the devices “may result in immediate and serious adverse health consequences, including death.”

The CS300 model has been associated with one patient death, which was reported to Datascope through a complaint. The unit failed to pump, and showed an electrical test failure code indicating that a solenoid valve required more power.

There are an estimated 12,000 affected units, and 5,049 of them were sold in the U.S. The pumps were approved for treatment of acute coronary syndrome or complications from heart failure.

Datascope is providing on-site services to install gaskets in the units and to upgrade software.