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Boston Scientific Recalls 29,000 Coronary Imaging Catheters–Tips Detaching

Posted May 29 2011 3:14am

One more recall and and the catheters being recalled will be from hospitals for the image most part.  We are still using the same old methodologies when a bar code could easily identify recalled products and devices.  Some hospitals use RFID to inventory but all are not equipped and even so some devices get missed being pulled from inventory.   At the bottom of this post is an article I wrote about a device that was missed and left on the shelf and caused death when the device malfunctioned.  Hopefully soon there’ will be a better way to handle recalls with using technology.  BD 

(Reuters) - Medical device maker Boston Scientific Corp said it has recalled more than 29,000 of its iCross coronary imaging catheters after receiving reports of the catheter tip detaching during procedures.

The recall involves 29,664 iCross catheters distributed in the United States, Puerto Rico, Trinidad, Tobago and the American Virgin Islands, the company said on Friday.

The voluntary recall was undertaken after the company received confirmed reports of eight occurrences of catheter tip detachments between April 1, 2010 and May 10, 2011.

The breakdown of the catheters while inside a blood vessel can cause blood clots, heart attacks, strokes and death.

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The company is notifying affected hospitals through detailed recall notification letters, including instructions on how to return recalled product. The notification and instructions may also be found on the Boston Scientific website. For additional information regarding this recall, please contact Boston Scientific at 1-800-811-3211.

 


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