Recalled Surgical Device Responsible For At Least 3 Deaths

If you’ve ever had to have a surgery, you know the fear that comes along with it.  Will I be ok?  Is this the right thing for me to do?  What will happen if I have trouble?  There are just so many uncertainties, and unfortunately when going under the knife, there is nothing you can [...]

Some Can Breathe Easier Due To Ventilator Recall That Is Potentially Saving Lives

According to various media reports, Respironics Inc.’s recall of a portable ventilator model, Respironics Trilogy 100, is nearly complete, the manufacturer said Thursday, January 12, 2012. The recall was initiated in October 2011 after internal reviews discovered a problem with the blower. Respironics notified its United States distributors, providers, sales personnel and customers of the [...]

FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump

FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without [...]

Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters

Cordis Corporation and FDA informed healthcare professionals of a Class I recall of All Fire Star and Dura Star balloon catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or [...]