The medical device maker said no deaths have been  associated with the problem and the recall classification does  not change recommendations made to physicians in January. The Food and Drug Administration defines a Class I recall  as a situation in which there is a reasonable probability that  use of the product will cause injury or death. According to the FDA Web site, a medical device recall does  not always mean that patients or doctors must stop using the  product or return it to the company. A recall sometimes means  the medical device needs to be checked, adjusted or fixed. Medtronic said in a statement that it sent an update on  January 16 to inform clinicians of an increase in the rate of  inflammatory mass cases reported in patients using its  SynchroMed and IsoMed infusion systems. The masses developed  near the tip of the catheter attached to the pumps, which are  typically used to dispense opioids for pain. Medtronic said the risk of an inflammatory mass has been  part of the product labeling since 2001. Medtronic shares, which fell 25 cents to close at $48.09 on  the New York Stock Exchange, were not trading after-hours.
FDA calls Medtronic drug pump warning Class I.