Boston Scientific recalls blood clot removal device
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Marlborough-based Boston Scientific has partnered with Minnesota's Mayo Clinic.
Boston Scientific, the Marlborough medical device manufacturer and developer, announced a voluntary worldwide recall of a device used to remove small blood clots from coronary arteries during thrombectomy procedures.
The Fetch 2 Aspiration Catheter was recalled March 22 after the company received complaints of shaft breakage during operations. The worst-case scenario of the breakage is either surgery to recover the fragments or an embolism of device fragments, which could lead to obstruction of blood flow, according to the company.
No reports of patient injury or death have been filed, and patients who underwent a thrombectomy where the device was used are not at risk. This was designated as a Class 1 recall by the U.S. Food and Drug Administration, meaning the use of the device exposes patients to the potential for serious adverse health consequences or death.
The recall applies to 21,155 devices on the market, packaged and labeled as a Bayer Medical Care Inc. product because Boston Scientific acquired the product line from Bayer. The Fetch 2 catheter was manufactured between June 11, 2014 and Feb. 19, 2016.
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