Boston Scientific is voluntarily recalling its iCross Coronary Imaging Catheters used in intravascular ultrasound imaging in patients who are candidates for transluminal coronary interventional procedures, according to a release from the company.
The recall, affecting almost 30,000 units, results from reports of catheter detachments due to embrittlement of the material. Potential health risks include vessel wall injury, thrombotic events, retained foreign body, foreign body embolization, myocardial infarction and death.
The recall does not affect patients who have already received treatment with the device because the potential problem occurs during the procedure. It also does not affect the company's Atlantis SR Pro, Atlantis ICE, Atlantis Ultra ICE, Atlantis .018, Atlantis PV and Sonicath Ultra 9 Catheters used with the iLab, ClearView and Galaxy IVUS imaging consoles.
At no cost, Boston Scientific will replace all returned iCross Coronary Imaging Catheters with Atlantis SR Pro Coronary Imaging Catheters.
Read the release on the Boston Scientific recall.
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