Medtronic's infusion pumps are implanted into the abdomen to gradually deliver drugs or fluids to patients. During the refill process, the inadvertent injection of all or some of the prescribed drug directly into the patient instead of the pump has resulted in drug overdose and death. On January 14, 2011, Medtronic sent a letter to physicians reminding them of the proper refill procedures. Medtronic has also taken steps to update the warning labels and instructions.
Despite these actions, on February 16, 2011, the U.S. Food and Drug Administration (FDA) issued a Class I recall on Medtronic's infusion pumps. Class I recalls are the most serious issued by the FDA. In order to classify as a Class I recall, there must be a reasonable probability that the use of the product will cause serious harm or death.
If you or someone you know has a Medtronic pain pump, contact your medical provider immediately to see whether this recall affects you.
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