Boston Scientific is recalling 29,664 units of its iCross Coronary Imaging Catheters because it has received confirmed occurrences of ".theter tip detachments due to embrittlement of the catheter material." The catheters are used in IVUS (intravascular ultrasound) imaging in patients who are confirmed as candidates for transluminal coronary intervention.
Percutaneous coronary intervention, also known as PCI, coronary angioplasty, or just angioplasty, is a procedure used to treated narrowed (stenotic) coronary arteries of the heart. They are caused by an accumulation of plaques that form due to atherosclerosis. The procedure is usually done by an interventional cardiologist.
The company informs that the catheters were delivered to the USA, American Virgin Islands, Trinidad and Tobago, and Puerto Rico. They are used with the following imaging devices - Galaxy®2, ClearView Ultra, or iLab® IVUS.
In a communiqué, the company adds:
"Boston Scientific'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.
Eight confirmed cases of catheter tip detachments due to embrittlement were reported between April and May 10 this year in Puerto Rico and the USA. A 0.027% failure rate.
As the risk of any danger only occurs during the procedure, patients who have already been treated with the recalled catheters are not affected. Boston Scientific has submitted details of a solution to the problem to the FDA (Food and Drug Administration).
If the catheter detaches there is a risk of vessel wall injury, bits being left behind inside the patient, foreign body embolization, thrombotic events, myocardial infarction, and death. So far most of the detachments have been retrieved.
Boston Scientific announced on its web site:
"Boston Scientific will replace, free of charge, all returned iCross Coronary Imaging Catheters with Atlantis SR Pro Coronary Imaging Catheters, which will operate with Boston Scientific's IVUS imaging consoles and are immediately available."
Shareholders have been told by the company that no material financial impact from this recall is expected.
Detailed recall notification letters are being sent to relevant hospitals, including instructions on how to return the devices. Those wanting further details can call the following number: 1-800-811-3211.