FDA calls Medtronic drug pump warning Class I

Medtronic Inc said on Wednesday that U.S. regulators classified its move to inform physicians about an increase in the rate of inflammatory mass cases in patients receiving drugs through the company’s implantable infusion pumps as a Class I recall.

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.