FDA: Class I recall of Medtronic’s HawkOne Directional Atherectomy System
Editor's Note The Food and Drug Administration (FDA) on January 21 identified the recall by Medtronic Inc of its HawkOne Directional Atherectomy System as Class I, the most serious. The recall was initiated because of the risk of the guidewire within the catheter moving down ward or prolapsing when force…
FDA: Class I recall of Getinge Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems
Editor's Note The Food and Drug Administration (FDA) on January 19 identified the recall by Getinge of its Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems as Class I, the most serious. The recall was initiated because of the potential chemical breakdown of Sevoflurane that may result in inhalation…
FDA: Class I recall of Medtronic Synergy Cranial, StealthStation S7 cranial software
Editor's Note The Food and Drug Administration (FDA) on January 6 identified the recall by Medtronic of its Stealth Station System with Synergy Cranial and StealthStation S7 Cranial Software as Class I, the most serious. The System aids in precisely locating anatomical structures in neurosurgical procedures. The recall was initiated…
FDA: Class I recall of Cardiovascular Systems’ WIRION Embolic Protection Device
Editor's Note The Food and Drug Administration (FDA), on January 10, identified the recall of Cardiovascular Systems’ WIRION Embolic Protection Device as Class I, the most serious. The device, which is used to hold or remove debris or blood clots from the lower limbs, was recalled because of complaints of…
FDA: Class I recall of Puritan Bennett 980 Series Ventilator
Editor's Note The Food and Drug Administration (FDA), on January 3, identified the recall by Covidien of its Puritan Bennett 980 Series Ventilator as Class I, the most serious. The recall was initiated because of a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop…
Meta-analysis finds high global percentage of asymptomatic COVID-19 infections
Editor's Note This study by Chinese researchers finds a high percentage of asymptomatic COVID-19 infections worldwide, which highlights the potential transmission risk of asymptomatic infections in communities. In this review and meta-analysis of 95 studies, which include nearly 30 million individuals undergoing testing, the percentage of asymptomatic infections was 0.25%…
FDA: Class I recall of Getinge/Datascope/Maquet Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps
Editor's Note The Food and Drug Administration, on December 16, identified the recall by Getinge/Datascope/Maquet of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The IABPs are cardiac assist devices used in patients having cardiac and noncardiac surgery and to treat patients…
Effectiveness of mRNA vaccines against COVID-19
Editor's Note This case-controlled study by researchers from White River Junction Veterans Affairs Medical Center, White River Junction, Vermont, and Dartmouth School of Medicine, Hanover, New Hampshire, finds that mRNA vaccine effectiveness against COVID-19 decreases significantly after about 6 months. In this analysis of 14,238 male veterans aged 65 or…
CDC: Surveillance of Omicron variant in US
Editor's Note On December 1, the first case of COVID-19 attributed to the Omicron variant was reported in the US, according to the Centers for Disease Control and Prevention (CDC). As of December 8, Omicron variant cases had been reported in 22 states, including some that indicated community transmission. Of…
Pfizer says COVID-19 booster protects against Omicron variant
Editor's Note On December 8, Pfizer said its COVID-19 booster was found to provide significant protection against the Omicron variant in a laboratory study, the December 8 Becker’s Hospital Review reports. Blood samples from those who received three doses of the vaccine saw similar neutralization against the Omicron variant as…
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- FDA announces multiple Class 1 recalls