Dec 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday classified a recall of Boston Scientific's BSX.N catheters used in a type of minimally invasive surgery as "most serious".
The recall involves updating instructions for use rather than removing the device, POLARx Cryoablation Balloon Catheters, from where they are used or sold, the FDA said.
The company meanwhile is revising the use instructions of the catheter due to a higher-than-anticipated number of reports of esophageal injury, specifically a complication known as atrio-esophageal fistula, which can lead to air bubbles blocking blood vessels in the brain.
The FDA said the use of the affected products may also cause stomach and intestinal bleeding, a system-wide infection, and even death.
There have been seven reported injuries and four deaths, the health regulator added.
On Oct. 10, Boston Scientific sent an urgent medical device advisory to all affected customers with recommendations.
Boston's device is used in ablation procedures to treat recurrent symptomatic atrial fibrillation that causes irregular, fast heartbeats lasting up to seven days and not responding to medication.
Ablation is a minimally invasive procedure used to treat atrial fibrillation by creating scars on the heart tissue.
(Reporting by Sriparna Roy in Bengaluru; Editing by Vijay Kishore)
((Sriparna.Roy@thomsonreuters.com;))
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。