2005年12月波士頓科學(xué)公司(Natick, MA, USA)宣布，在全球范圍內(nèi)召回氣囊血管成形術(shù)的設(shè)備，該設(shè)備用于治療被堵塞的冠狀動(dòng)脈。

這次召回涉及大約40,000套Flextome切割血管成形氣囊設(shè)備，是由于該公司聲稱接到8例報(bào)道，稱導(dǎo)管遠(yuǎn)端軸會(huì)在抽出設(shè)備的時(shí)候發(fā)生脫落。在其中3例中，需要手術(shù)來(lái)取出脫落末端。波士頓科學(xué)公司稱該公司正在和美國(guó)食品藥品管理具合作，進(jìn)行召回工作并通知了其它國(guó)家的衛(wèi)生管理當(dāng)局。

召回的產(chǎn)品是Flextome切割氣囊設(shè)備單軌輸送系統(tǒng)，外周切割氣囊微手術(shù)擴(kuò)張?jiān)O(shè)備小單軌輸送系統(tǒng)。血管成形氣囊被用于狹窄動(dòng)脈的再通，并擠壓動(dòng)脈壁上沉積的斑塊。Flextome設(shè)備與標(biāo)準(zhǔn)血管成形氣囊不同，在其外端有3或者4個(gè)微型手術(shù)刀片(叫做atherotomes)。

這是在1周之內(nèi)波士頓科學(xué)公司第二次召回產(chǎn)品。在上周該公司宣布召回大約18,000套不銹鋼Greenfield vena cava過(guò)濾裝置，該裝置設(shè)計(jì)用于過(guò)濾溶解血凝塊以保護(hù)肺臟。
 
 
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.