Boston Scientific is voluntarily recalling all of the iCross Coronary Imaging Catheters used in intravascular ultrasound (IVUS) imaging in patients who are candidates for transluminal coronary interventional procedures in the US, Puerto Rico, Trinidad, Tobago and the American Virgin Islands.
The action is being taken due to eight occurrences of catheter tip detachments due to embrittlement of the catheter material, in the US and Puerto Rico.
The catheters are intended to operate with Boston Scientific‘s ClearView Ultra, Galaxy, Galaxy2 or iLab IVUS imaging consoles.
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 are not impacted by this recall, with the Atlantis SR Pro available immediately as a substitute.
The current action does not affect patients who have already received treatment with the recalled devices because the potential problem occurs during the procedure.
Boston Scientific said it will replace, free of charge, all returned iCross Coronary Imaging Catheters with Atlantis SR Pro Coronary Imaging Catheters, which will operate with the company’s IVUS imaging consoles and are immediately available.
The US Food and Drug Administration has determined the action is a Class I recall.