CLASS I RECALL There isan updateto the recent Salmonella outbreak linked to eggs being recalled in nine states, including Minnesota. The FDA says there is 'reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.' EGG ...
“The IntraClude balloon bursting may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass, including neurological damage, embolism, stroke and death,” the FDA notes in a MedWatch safety alert. The agency has classified the recall as Class I...
Spine Surgery | The FDA announced the Class I recall of the Medtronic Neurosurgery, Medtronic Duet External Drainage and Monitoring System in a press release and noted the system’s patient line tubing may separate from the patient line connector...
On January 19, 2023, the FDA issued a Class I recall to ensure all LifeSPARC controllers are updated to software version 1.1.5. LivaNova began actively updating all LifeSPARC controllers to software version 1.1.5 with customers on December 5, 2022 and are nearing 100% completion. Software ve...
The US Food and Drug Administration (FDA) todayissueda class I recall of theSapien 3 Ultradelivery system, used to deploy the Edwards Lifesciences transcatheter heart valve in patients withaortic stenosis. Aspreviously reported, the device maker warned physicians last month that it had received an...
This prompted the FDA’s class I tag, the highest and most serious type of recall. “Even a single drop could result in reduced battery life, either immediately after the drop, or over time, and will continue to affect the pump even after replacing the battery,” Medtronic said in a ...
7. Adverse Event(不良事件): 指与使用医疗器械相关的任何不期望的或意外的事件,可能导致或可能导致患者、用户或其他人的死亡、严重伤害或严重疾病。 8. Recall(召回): 当医疗器械存在安全隐患或不符合 FDA 要求时,制造商可能需要发起召回行动,以收回市场上的问题器械。
The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif. OVDs are viscoelastic materials used to maintain space in the eye during...
Today, the FDA categorized this action as a Class I recall, its most serious type, meaning that use could cause serious injuries or death. The devices are being recalled due to an unexpected and rapid decrease in battery life caused by a short circuit. This defect may case some devices to...
Editor's Note The Food and Drug Administration (FDA) on March 6 identified the recall by Becton Dickinson (BD)/CareFusion 303 of its Alaris System