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Class 1 Recall: Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to Risk of Valve Failure Preventing Balloon Inflation and Deflation
Mon Aug 07 2017

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....


Class 1 Recall: Updated Status of FUJIFILM Medical Systems, U.S.A., Inc. Model ED-530XT Duodenoscopes: FDA Safety Communication
Thu Jul 27 2017

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


Class 1 Recall: Navigational Accuracy Errors Associated with Frameless Stereotaxic Navigation Systems: FDA Safety Communication
Thu Jun 15 2017

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


Class 1 Recall: Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators Due to Potential of Harmful Chemicals Which May Be Toxic to Tissues and Organs
Wed May 31 2017

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....


Class 1 Recall: Magellan Diagnostics Inc. Recalls LeadCare Plus and Ultra Testing Systems Due to Inaccurate Test Results
Fri May 26 2017

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....


Class 1 Recall: Abbott Vascular Recalls Coronary Catheters Due to Risks Stemming from Difficulty Removing Balloon Sheath
Wed May 24 2017

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....


Class 1 Recall: Abbott-Thoratec Recalls HeartMate II LVAS Pocket System Controller Due to Risk of Patient Injury and/or Death during Backup Controller Exchange
Wed May 24 2017

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


Class 1 Recall: Respironics California Recalls the V60 Non-invasive Ventilator Due to Faulty Cable Pins That May Cause the Device to Shut Down Unexpectedly
Wed May 24 2017

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....


Class 1 Recall: ReFlow Recalls Wingman 35 Crossing Catheters due to Tip Separation
Wed May 17 2017

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


Class 1 Recall: Medtronic Recalls StrataMR Adjustable Valves and Shunts Which May Cause Fluid Buildup in the Brain
Thu Apr 20 2017

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....

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