Medtronic recalls 6 French Sherpa NX active guide catheters

美美敦力公司主动召回Sherpa NX活性导管

2019-10-09 16:47:26 Mass Device


Medtronic  said today that it recalled all models of its 6 French Sherpa NX active guide catheters due to a material problem that could result in exposed wires. The Fridley, Minn.-based company said the devices were recalled because of a risk of the outer material of the catheter separating from the device, resulting in detached fragments that could expose the underlying stainless steel braid wires. The fragments could remain in a patient’s bloodstream, which, along with attempts to retrieve the fragments, could result in blockage of blood vessels, injury to blood vessel walls, development of blood clots, embolism, heart attack or death. Medtronic said it received five customer complaints regarding the device, but no serious injuries or deaths were reported. The company said the recall will not affect the Medtronic Launcher coronary guide catheter or any other Medtronic coronary stents, balloons or implantable devices. The FDA identified the recall as a Class I recall, denoting the risk of serious injuries or death. Medtronic said that it recalled 106,298 devices in the U.S. that were manufactured between March 10, 2017, and March 14, 2019, and distributed between April 3, 2017, and April 4, 2019. Medtronic initiated the recall on March 15. The 6 French Sherpa NX active guide catheter is designed to access veins and arteries both inside and outside the heart, potentially to pair with guidewires and other interventional devices for administering drugs or fluids into blood vessels. Shares of MDT were down -1.6% at $105.57 per share in mid-afternoon trading today.
美美敦力(Medtronic)公司今天说,它召回所有型号的6法国 Sherpa NX 活性导管,由于一个物质问题,可能导致暴露电线。 明尼苏达州的弗里德利。这家总部位于美国的公司表示,这些设备之所以被召回,是因为这些设备存在导管从设备中分离出来的外部材料的风险,导致分离的碎片可能暴露出潜在的不锈钢编织电线。这些碎片可能会留在病人的血液中,再加上试图提取碎片,可能导致血管阻塞、血管壁受伤、血栓形成、栓塞、心脏病发作或死亡。 美美敦力(Medtronic)表示,该公司收到了5名客户对该设备的投诉,但没有严重受伤或死亡的报道。该公司表示,此次召回不会影响 Medtronic Launcher 冠脉导管或任何其他美敦力(Medtronic)冠脉支架、球囊或植入式设备。 美国食品和药物管理局将此次召回确定为 I 级召回,表示可能发生严重受伤或死亡。美美敦力(Medtronic)表示,它召回了2017年3月10日至2019年3月14日期间在美国生产的106,298台设备,并在2017年4月3日至2019年4月4日之间进行了分销。美美敦力(Medtronic)于3月15日发起召回行动。 6法国 Sherpa NX 主动导引导管的设计是为了进入心脏内外的静脉和动脉,有可能与导引装置和其他介入装置结合使用药物或液体进入血管。 今日下午交易中, MDT 股价下跌-1.6%,至每股105.57美元。