Company:Datascope Corp./MAQUET.
Date of Enforcement Report 9/6/2017
Class II:
PRODUCT
Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump.
The devices addressed in this communication are the following St. Jude Medical pacemaker and CRT-P devices: Accent, Anthem, Accent MRI, Accent ST, Assurity, Allure
This communication does NOT apply to any implantable cardiac defibrillators (ICDs) or to cardiac resynchronization ICDs (CRT-Ds).
Datascope Corp./MAQUET’s CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps (IABP) are cardiac assist devices used to assist patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.
REASON
Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps manufactured July 1, 2003 to June 16, 2017 due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump. If a patient requires circulatory support with an IABP and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.
RECALLING FIRM/MANUFACTURER
On July 17, 2017, Datascope Corp./MAQUET sent affected customers an “Urgent Product Recall Medical Device Field Correction” notice informing them of the device’s risks, and listing actions that should be taken to minimize the risk of patient harm until affected IABP units can be serviced.
VOLUME OF PRODUCT IN COMMERCE
5,049
DISTRIBUTION
Nationside
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