丨Abiomed 心脏泵和 TAVR 支架之间的干扰导致四人死亡 2023年7月18日,强生旗下分公司 Abiomed 在短短几个月内第二次被 FDA 一级召回(Class I recall designation)。强生子公司 Abiomed 报告称, 该公司的 Impella 心脏泵和经导管主动脉瓣置换支架之间的相互作用导致 4 人死亡和 26 人受伤。 Abiomed 在发现 TAV...
FDA class 1 recall for some Abiomed Impella heart pumpsBrooks, MeganCardiology News
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...
The Food and Drug Administration (FDA) on March 6 identified the recall by Becton Dickinson (BD)/CareFusion 303 of its Alaris System Infusion Pumps and Modules as Class I, the most serious. The recall was initiated because of multiple system errors, software errors, and use-related errors. ...
1. Medical Device(医疗器械): 指仪器、设备、器具、机器、用具、植入物、体外试剂或其他类似或相关物品,包括任何组件、零件或附件,其主要预期用途是用于人类疾病或其他状况的诊断、治疗、缓解、预防或监测,或者旨在影响人体的结构或功能。 2. Class I/II/III(I/II/III 类医疗器械): ...
NeuroBlate laser delivery probes, part of the NeuroBlate System from Monteris Medical, may overheat, causing patient injury, the FDA warns, and are subject to an ongoing Class I recall.
2023年2月15日、16日,FDA连发两条Class I类召回指令(注1)。 也不知道为什么,Title是2022,这里应该是2023才对。 FDA 的召回分为三个等级(注2),其中,Class I 类召回是FDA认定的最严重等级的召回事件。 在这个等级,产品缺陷被认为可能对人产生严重的健康损害甚至死亡。
June 4, 2018 — The U.S. Food and Drug Administration said Medtronic initiated a Class 1 recall all 204,017 of its HeartWare Ventricular Assist Devices (HVAD) produced between March 2006 to May 2018. Medtronic said there is a possibility for an interruption to occur in the electrical connect...
We acknowledge your firm initiated a Class I recall on June 27, 2023, for six batches of Albuterol Sulfate Inhalation Aerosol due to a defective valve lot that had a partially missing bottom seat (gasket). However, your firm failed to perform a comprehensive risk assessment byextending the inv...
The article reports that the recall of intravenous (IV) administration sets from pharmaceutical and medical device company Hospira was reported by the Food and Drug Administration (FDA) on August 14, 2013, is a class I recall due to the possibility of puncture-related leakage of blood bags.年份...