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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....


Class 1 Recall: Merit Medical Systems, Inc. Recalls the Prelude® Short Sheath Introducer - Sheath May Separate During Use
Fri Mar 31 2017

Merit Medical Systems Inc. is recalling the Prelude® Short Sheath Introducer due to a manufacturing defect which may cause the tip to separate from the sheath during the insertion procedure....


Class 1 Recall: Phillips Healthcare recalls HeartStart MRx Monitor/Defibrillator due to electrical issues that may prevent the device from operating properly
Fri Mar 24 2017

Phillips is recalling the HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy....

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