On Wednesday, Medtronic announced that the FDA has informed them that it has classified its communication to physicians related to inflammatory mass formation associated with intrathecal drug delivery as a Class I Recall.  On January 16, 2008, Medtronic sent a letter to inform clinicians worldwide of an increase in the rate of reported inflammatory mass cases in patients who have received intrathecal drug delivery through its implantable infusion systems. Even though Medtronic has issued communications regarding this issue since 2001 it was still deemed necessary by the FDA to issue a class I recall, something that Medtronic has downplayed. Physicians and patients will need to do nothing regarding this issue as it is Medtronic’s responsibility to follow the guidelines set by the FDA.

 Regarding FDA recalls, many people are confused when the FDA issues a recall, evident in this 2002 brochure released by the FDA to help explain its recall policies. Some interesting points, The FDA has a classification system regarding recalls which is as followed:

“The guidelines categorize all recalls into one of three classes according to the level of hazard involved.

• Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.
• Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature.  One example is a drug that is under-strength but that is not used to treat life-threatening situations.
• Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations. Examples might be a container defect (plastic material delaminating or a lid that does not seal); off-taste, color, or leaks in a bottled drink, and lack of English labeling in a retail food.”

From this information we can see that even though Medtronic is issuing a press release saying that this recall is a non-issue, the fact that the FDA has classified this as class I would suggest otherwise.