Device Safety

Latest Headlines

Latest Headlines

FDA says duodenoscopes failed disinfection test, plans advisory committee hearing

Following an outbreak of a deadly antibiotic-resistant pathogen in Illinios linked to a type of endoscope known as a duodenoscope, the FDA tested the cleaning protocols of the device's manufacturers. Their disinfection systems failed. That means future patients undergoing duodenoscope procedures are at risk of picking up the deadly CRE bacteria too.

St. Jude settles 70 suits related to Riata defibrillator leads for $14.25 million

St. Jude Medical agreed to pay as much as $14.25 million to settle about 950 claims related to its Riata defibrillator leads. The wires used to shock a heart that is beating abnormally degraded in as few as four years and were pulled from the market in 2010. 

More lawsuits planned as infected endoscope safety scare grows

The duodenoscope safety saga is growing ever more dramatic. The infected endoscopes for visualization of the bile and pancreatic duct have left dead patients in their wake, since at least 1987, it turns out. Are duodenoscopes this year's equivalent of power morcellators? Attorney Peter Kaufman plans four to six additional lawsuits against duodenoscope manufacturer Olympus, including three wrongful death suits related to an outbreak of the antibiotic-resistant "superbug" known as CRE.

UnitedHealth to require prior authorization for gynecological procedures amid morcellator pushback

Amid growing backlash over the use of laparoscopic power morcellator devices in minimally invasive gynecological procedures, the U.S.'s largest health insurer is tightening its reins on coverage for hysterectomies.

FDA weighs in on Intuitive Surgical recall of da Vinci vessel sealer due to inadequate grasping

The FDA issued a pair of Class II recall notices on Feb. 24 for the EndoWrist One Vessel Sealer. The agency said the device may "exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws." 

FDA in midst of updating endoscope labels implicated in 'superbug' infections

The U.S. Food and Drug Administration is working to update the labels for duodenoscopes linked to the recent "superbug" outbreak that were inadequately cleaned, according to a Reuters report.

Hospital, FDA remain at odds on effective endoscope cleaning as 'superbug' marches on

The FDA has warned that even if healthcare providers clean endoscopes according to manufacturer recommendations, a risk of infection still remains.

HeartWare issues recall again for implantable heart pumps due to risk of death

HeartWare has issued a voluntary recall of some of its Ventricular Assist System Controllers due to their higher susceptibility to electrostatic discharge than some newer, commercial controllers. An electrostatic discharge can cause a pump to stop, which could result in serious injury or death.

Advisory panel recommends FDA approval of VertiFlex's spinal implant

An orthopedic advisory panel voted to approve Vertiflex's PMA application to the FDA for its Superion Interspinous Spacer, a spinal implant designed to treat moderate lumbar stenosis and pain, numbness and/or leg cramps related to the condition.

GE explains the recall of its MRI systems to FierceMedicalDevices

GE told FierceMedicalDevices in an email that the recall was voluntarily initiated following a single safety incident in India, where some users had disabled the so-called magnetic rundown unit, because the company "wanted to ensure that the human error was not occurring at other sites globally."