Boston Scientific is recalling nearly 30,000 coronary imaging catheters following eight instances of the tips breaking off during procedures.
The company says potential risks include heart attack and death.
A company statement did not indicate whether any patients have been harmed but said the majority of detachments were successfully retrieved.
Two instances reported to the FDA said the patients were fine after the tip broke. Boston Scientific says patients who have already received treatment with the recalled devices are not affected because the potential problem occurs during the procedure.
Boston Scientific says it has told the FDA how it will solve the problem and is waiting federal approval. Boston Scientific is based in Massachusetts but employs some 5,000 people in Minnesota.