IABPs Recalled Due to False Blood Detection Alarms and Ingress of Fluid
The FDA’s Class I recall affects over 5,000 devices manufactured by Datascope Corp/MAQUET between 2003 and 2017.
Datascope Corp/MAQUET is recalling certain models of intra-aortic balloon pumps (IABPs) due to the potential for false blood detection alarm and fluid ingression into the device, the US Food and Drug Administration (FDA) announced today.
The recall carries the FDA’s most serious Class I designation, because failure of an IABP may result in immediate and serious adverse health consequences, including death.
Affected models are the CS100i, CS100, and CS300, with the recall pertaining to all lots of these models that were manufactured between July 1, 2003, and June 16, 2017. The recall notice states that 5,049 devices are involved.
Datascope Corp/MAQUET initiated the recall on July 17, 2017, in the form of an “Urgent Product Recall Medical Device Field Correction" notice, advising that it was taking steps to provide on-site service visits to customers to install gaskets in the IABP units and upgrade software, and noting that clinicians should follow the instructions on the blood detection alarm help screen to validate or clear the alarms.
Earlier this summer, as reported by TCTMD, the company issued a recall for certain lots the same models over the potential for electrical test failure, which the FDA subsequently updated to a Class I.
US Food and Drug Administration. Intra-aortic balloon pumps by Datascope/MAQUET: Class I recall - false blood detection alarm, ingress of fluid into pump. Published and accessed on: September 6, 2017.