Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps manufactured before June 30, 2013 due to the risk of a valve failure which prevents the balloon from inflating and deflating properly....

The FDA is issuing this communication to provide updated status information about FDA clearance of Fujifilm's ED-530XT and to amplify Fujifilm's Urgent Medical Device Correction and Removal notice, issued on July 21, 2017....

The FDA is aware that some health care providers have experienced navigational accuracy errors during surgical procedures when using frameless stereotaxic navigation systems....

Zimmer Biomet is recalling the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals....

Magellan Diagnostics is recalling the LeadCare Plus and the LeadCare Ultra Testing Systems because they may underestimate the blood lead levels (BLL) and give inaccurate results when processing venous blood samples....

Abbott has initiated a recall of specific lots of three catheters due to 19 reports of injury, and 1 report of death associated with difficulty removing the protective balloon sheath, resulting in issues with inflating or deflating the balloon....

Patients may sometimes need to change to their backup back-up system controller during the course of ventricular assist therapy....

Respironics is recalling the V60 Non-invasive Ventilator because the pins within the internal cable that connects the ventilator's motor to the control board may become loose over time due to low frequency vibration....

Reflow is recalling the Wingman 35 Crossing Catheter due to a risk of the catheter tip splitting or separating....

Medtronic is recalling the StrataMR Adjustable Valves and Shunts due to a design problem which may cause the valve opening pressures to be higher than specified and increase the resistance to the cerebrospinal fluid flow....