Boston Scientific to Recall Additional Coronary Stent Systems | 合法醫療器材資訊網

OnJuly2,theCompanyannouncedtherecallofapproximately200TAXUSExpress2Paclitaxel-ElutingCoronaryStentSystems,duetocharacteristicsinthe ...

(July 16, 2004) -- Boston Scientific Corporation (NYSE: BSX) announced today that it is expanding its voluntarily worldwide recall to include certain additional units of its TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent Systems. The Company is also beginning a voluntary recall of certain units of its Express2™ Coronary Stent Systems (bare metal stents). The Company has notified the U.S. Food and Drug Administration (FDA) and plans to notify officials in other affected countries.

On July 2, the Company announced the recall of approximately 200 TAXUS Express2 Paclitaxel-Eluting Coronary Stent Systems, due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure. Since then, the Company has conducted further analysis and investigation of the TAXUS Express2 (paclitaxel-eluting) and Express2 (bare metal) stent systems, both of which share the same...

Taxus and Express2 Coronary Stents Recalled | 合法醫療器材資訊網

TAXUS and Express2 Coronary Stents Recalled | 合法醫療器材資訊網

85,000 TAXUS and 11,000 Express2 Stents affected. Boston Scientific Express2 (bare metal) coronary stent system is the subject of a Class I recall because of ... Read More

Class 1 Device Recall Taxus | 合法醫療器材資訊網

... recall letters were sent to user accounts, such as Hospitals and clinics of the need to recall TAXUS Express2 Paclitaxel-Eluting and Express 2 Coronary Stent ... Read More

FDA Announces Recall of Express2 Coronary Stent System | 合法醫療器材資訊網

2004年7月24日 — The recall was based on catheter design characteristics that resulted in failure of the balloon to deflate, impeding its removal after stent placement ... Read More

Boston Scientific to Recall Additional Coronary Stent Systems | 合法醫療器材資訊網

On July 2, the Company announced the recall of approximately 200 TAXUS Express2 Paclitaxel-Eluting Coronary Stent Systems, due to characteristics in the ... Read More

Boston Scientific Recalls 200 TAXUS™ Stent Systems | 合法醫療器材資訊網

... BSX) announced today that it is voluntarily recalling nationwide approximately 200 units of its TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent Systems ... Read More

Boston Scientific recalls Taxus Express2 stents | 合法醫療器材資訊網

2004年7月7日 — Boston Scientific Corp. announced July 2 it will recall 200 of its recently approved drug-coated coronary stents because of a malfunction that ... Read More

Boston Scientific TAXUS Express2 Drug | 合法醫療器材資訊網

2009年10月14日 — Nearly 100 hospitals in the United States use the Taxus stent. Boston Scientific expanded its recall to include 85,000 Taxus drug-coated stents, ... Read More

Recall of Device Recall Taxus | 合法醫療器材資訊網

According to U.S. Food and Drug Administration, this recall involved a device in ... to recall TAXUS Express2 Paclitaxel-Eluting and Express 2 Coronary Stent ... Read More

Boston Scientific Expands Recall Of Troubled Stent | 合法醫療器材資訊網

2004年8月6日 — Boston Scientific first recalled a small number of Taxus stents in early July after doctors said they were having difficulty removing the balloon ... Read More

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