ev3 Nanocross Balloon Catheter Recall Issued

A serious and potentially life-threatening defect has led to the recall of some lots of the ev3 NanoCross Dilation Catheter. 

On December 28, the FDA announced that Covidien had issued a catheter recall for NanoCross catheters, which are used to dilate stenoses in arteries and used to treat obstructive lesions. The recall was issued after it was found that the shaft of the catheter can crack or break during use.

A cracked catheter shaft can prevent the balloon from inflating or deflating, it could also send fragments into the patient, potentially causing an embolism. If the catheter fails it could lead to additional surgery, cause severe injury, bleeding or death. The FDA has classified the market removal as a Class I recall, which is used for the most serious recalls, where the medical device has a reasonable possibility of causing serious injury or death. Neither Covidien nor FDA released information on whether there had been any injuries or deaths associated with the product.

The recall affects about 240 lots of the ew3NanoCross .014” OTW PTA Dilation Catheter. The catheters were manufactured between May 27, 2010 and October 18, 2010. The lot numbers are printed on the front and sides of the packaging.

Covidien sent a letter to healthcare facilities that used the catheters on November 10, informing them of the problem. The letter also contained instructions on returning and disposing of affected catheters.

The FDA recommends that any healthcare facilities using the catheters immediately locate and remove them from use.

The agency also asks both health care providers and patients to report any adverse events to the FDA MedWatch program at www.fda.gov/MedWatch/report.htm.