Medtronic warned doctors in January of an increase in inflammatory masses around their implantable infusion pumps. The warnings involved the SynchroMed and IsoMed infusion pumps. They deliver medications to patients. The FDA has now said that makes it a Class I recall.
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.
The masses are happening around the catheter attached to the pump. Medtronic says mention of masses as a side effect of the pump has been in product labeling since 2001.