波士顿科学公司召回血管成形术设备

 
2005年12月波士顿科学公司(Natick, MA, USA)宣布，在全球范围内召回气囊血管成形术的设备，该设备用于治疗被堵塞的冠状动脉。

这次召回涉及大约40,000套Flextome切割血管成形气囊设备，是由于该公司声称接到8例报道，称导管远端轴会在抽出设备的时候发生脱落。在其中3例中，需要手术来取出脱落末端。波士顿科学公司称该公司正在和美国食品药品管理具合作，进行召回工作并通知了其它国家的卫生管理当局。

召回的产品是Flextome切割气囊设备单轨输送系统，外周切割气囊微手术扩张设备小单轨输送系统。血管成形气囊被用于狭窄动脉的再通，并挤压动脉壁上沉积的斑块。Flextome设备与标准血管成形气囊不同，在其外端有3或者4个微型手术刀片(叫做atherotomes)。

这是在1周之内波士顿科学公司第二次召回产品。在上周该公司宣布召回大约18,000套不锈钢Greenfield vena cava过滤装置，该装置设计用于过滤溶解血凝块以保护肺脏。
 
 
Boston Scientific Recalls Angioplasty Devices
 
A worldwide recall of balloon angioplasty devices meant to treat blocked coronary arteries was announced in December 2005 by Boston Scientific (Natick, MA, USA).

The recall, involving about 40,000 Flextome cutting angioplasty balloon devices, came after the company said it had received eight reports that the distal shaft of the catheter may separate during withdrawal of the device. In three of the cases, surgery was required to remove the detached end. Boston Scientific said it was working with the U.S. Food and Drug Administration (FDA) on the recall and is also notifying health officials in other countries.

The products recalled are the Flextome cutting balloon device monorail delivery system and the peripheral cutting balloon microsurgical dilatation device small monorail delivery system. Angioplasty balloons are used to reopen narrowed arteries and push back accumulated plaque in the arteries. The Flextome device differs from standard angioplasty balloons in having three or four microsurgical blades (called atherotomes) on its exterior.

This is the second recall of a Boston Scientific device within a week. Last week, the company announced a recall of about 18,000 stainless steel Greenfield vena cava filters designed to filter and dissolve blood clots in order to protect the lungs.