FDA expands recall of IVUS catheters
Boston Scientific has expanded its recall of intravascular ultrasound (IVUS) catheters beyond its iCross line to its Atlantis A SR Pro2 line due to reports that the catheter tip can break inside of the patient and embolize causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery.
In late May, the company commenced a voluntary recall of nearly 30,000 iCross catheters that were distributed in the U.S. and U.S. territories, after multiple confirmed cases of catheter tip detachments in the iCross coronary imaging catheters. The devices, used in IVUS in patients who are candidates for transluminal coronary interventional procedures, are part of an FDA Class I recall.
Natick, Mass.-based Boston Scientific said it notified its customers by letter on May 27, describing the problem, the potential hazard and the action to be taken. Customers were instructed to discontinue use and return all products to the company.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
In late May, the company commenced a voluntary recall of nearly 30,000 iCross catheters that were distributed in the U.S. and U.S. territories, after multiple confirmed cases of catheter tip detachments in the iCross coronary imaging catheters. The devices, used in IVUS in patients who are candidates for transluminal coronary interventional procedures, are part of an FDA Class I recall.
Natick, Mass.-based Boston Scientific said it notified its customers by letter on May 27, describing the problem, the potential hazard and the action to be taken. Customers were instructed to discontinue use and return all products to the company.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.