FDA designates Class I recall for neurosurgery software
Editor's Note The US Food & Drug Administration (FDA) has classified Medtronic’s recall of its StealthStation S8 software as a Class I, the most severe category indicating risk of serious injury or death. The StealthStation System with StealthStation Cranial software is intended as an aid for locating anatomical structures during…
Class 1 recall announced for ambulatory infusion pump
Editor's Note The US Food and Drug Administration (FDA) has designated OptumHealth Care Solutions’ recall of the Nimbus II ambulatory infusion pumps a class 1, the most severe category indicating risk of serious injury or death. According to the agency’s May 30 announcement, the company recalled the pumps in direct…
FDA announces Class 1 recall for Vyaire Medical’s Twin Tube CPX sample lines
Editor's Note A choking hazard prompted the US Food and Drug Administration (FDA) to designate Vyaire Medical’s recall of Twin Tube sample lines—critical components of the Vyntus CPX system—as Class 1, the most serious category of recall indicating a risk of serious injury or death. According to the agency’s May…
How awareness evolves to action on surgeon, patient gender gaps
Takeaways Although women comprise half the population, they were left out of medical research on major causes of death for both women and men—cancer, heart disease, and stroke—until 1990. Using surgical tools designed by men, for men can impact every aspect of a woman surgeon’s work, from learning new procedures…
Surgery-preventing spinal stimulation poised for FDA approval
Editor's Note A recent trial marks the last hurdle for researchers to request regulatory approval for a noninvasive alternative to spinal surgery, according to a May 20 report in MIT Technology Review. Onward Medical’s ACRex device delivers electrical stimulation to the spinal cord via two wired electrodes placed just below…
Study: Transcatheter aortic valve replacement offers similar outcomes to surgical aortic valve replacement
Editor's Note The largest scale analysis so far available comparing surgical aortic valve replacement (SAVR) to longer-term percutaneous devices for transcatheter aortic valve replacement (TAVR) supports the comparable long-term safety and efficacy of the latter procedure. According to a May 15 report in Medical Xpress, the findings raise important considerations for valve…
Long-lasting heart valves poised to set world record
Editor's Note More than 45 years after surgery, Mary Ann Kozlowski’s mechanical heart valves are still pumping—and Guinness is reviewing an application to list her as the new world record-holder for longevity of a double-valve replacement. That’s according to a May 15 report in the Erie-Times News, which detailed how…
FDA announces class 1 recalls for heart devices, ventilators
Editor's Note The US Food and Drug Administration (FDA) has classified recalls of Abbot’s HeartMate 3 Left Ventricular Assist System (LVAS) implant kits and Phillips Respironics' Trilogy Evo ventilators as class 1, the most serious category indicating risk of serious injury or death. Used while waiting for recovery, a transplant,…
FDA issues class 1 recall for medical catheters
Editor's Note The US Food and Drug Administration (FDA) has designated Route 92 Medical’s recall of products containing the Tenzing 7 delivery catheters as class 1, the most serious classification indicating risk of serious injury or death. The devices are used to deliver microcatheters to the blood vessels in the…
FDA warns of continued cardiac pump safety concerns after series of recalls
Editor's Note The US Food and Drug Administration (FDA) is urging healthcare providers to avoid using Getinge heart devices due to continued safety concerns that remain unaddressed despite previous recalls. Issued to healthcare providers May 8, the warning letter applies to Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices…
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