UPDATED 5/30/2011 at 2:00 p.m.

Boston Scientific Corp. (NYSE:BSX) recalled all 30,000 of its iCross coronary imaging catheter after confirming eight instances in which the device’s tip detached during procedures.

The Natick, Mass.-based medical device maker said it’s voluntarily pulling about 29,700 of the devices due to “embrittlement of the catheter material,” according to a press release. The eight detachments the company confirmed in the U.S. and Puerto Rico happened between April 1 and May 10, according to the release, and amounted to a rate of 0.027 percent based on “available market data.” The FDA hit the recall with a Class I rating, its most serious.

“Potential health risks associated with this type of failure include vessel wall injury, thrombotic events, retained foreign body, foreign body embolization, myocardial infarction and death. There are additional risks to health associated with retrieval attempts (percutaneous or surgical),” BSX said. “To date, the majority of confirmed brittle tip detachments have been successfully retrieved (typically snared percutaneously). Because the potential for tip detachment is undetectable prior to use, modifications to the IVUS procedure will have little impact on the likelihood of occurrence of these events.”

In an emailed statement, a Boston Scientific spokesman told MassDevice that no deaths have been reported in connection with the problem, but failed to respond to questions about whether there were any injuries. BSX submitted a plan for a fix to the problem to the FDA and plans to resume shipments once it wins approval for the fix from the federal watchdog agency.

Customers affected by the recall will be given free Atlantis SR Pro imaging catheters to replace the recalled iCross. That device was distributed in the United States, Puerto Rico, Trinidad, Tobago and the American Virgin Islands.

Boston Scientific is asking customers to report any adverse “reactions” from using the device to the company and to the FDA’s MedWatch program (1-800-FDA-1088).