Boston Scientific iCross Catheter Recall: Risk of Tip Detachment
A recall has been issued for all Boston Scientific iCross Coronary Imaging Catheters due to defective tips that could detach, potentially causing a heart attack, foreign body embolism or death.
The Boston Scientific iCross catheter recall was announced on May 27, after the manufacturer received at least eight reports of catheter tips detaching in the United States and Puerto Rico.
The FDA has classified the action as a Class 1 medical device recall, meaning the agency has determined there is a reasonable probability of serious injury or death from the iCross Coronary Imaging Catheters.
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Boston Scientific reports that the catheter tips detach due to brittleness of the catheter material. The company also reported that the majority of the defective catheter tips that broke off have been successfully retrieved. However, the company did not indicate in their press release the number of times retrieval attempts failed or whether there were any serious injuries or deaths associated with the defective catheters.
The iCross catheters are used during intravascular ultrasound (IVUS) imaging in patients who are candidates for transluminal coronary interventional procedures. According to the company, the risk occurs only during implantation of the catheter and patients who have successfully had the catheters implanted are not at risk.
If a catheter tip detaches from the Boston Scientific iCross, it can cause injuries to blood vessel walls, thrombotic events, foreign body embolization, heart attacks and death.
All iCross Coronary Imaging Catheters are affected by the catheter recall. They are designed to operate with Boston Scientific’s ClearView Ultra, Galaxy, Galaxy 2 and iLab IVUS imaging consoles. Nearly 30,000 units are affected by the recall. The devices were distributed to hospitals in the U.S., Puerto Rico and other U.S. territories.
The company is in the process of notifying hospitals who purchased the recalled catheters through recall notification letters. Any customers seeking additional information can contact Boston Scientific at 1-800-811-3211.
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