Medtronic announced it is recalling infusion pumps and refill kits used to provide long-term, continuous or intermittent drug infusion because of the potential for the pump to be misused, which can cause unintentional overdoses. This misuse has been linked to eight deaths and 270 events that required medical intervention since 1996.

The recall is a Class 1, which is the most serious type of recall the Food and Drug Administration (FDA) can give and involves cases in which there is the potential for serious harm or death. Medtronic is not actually recalling the products, specifically the SynchoMed II and SynchroMed EL pumps, as the problem is not related to a defect, but by misuse by medical personnel and caregivers. The issue is caused when refills of the drugs are accidentally injected directly into the patients all at once rather than into the pump for gradual administration of the medication. 

Rather than removing the product, healthcare providers were alerted by urgent letter in mid-January of the need to check needle placement within the pump during the drug-refill procedure to make sure the fluids are deposited in the pump reservoir and not directly into the patient.

The Medtronic SynchroMed II and the SynchroMed EL Implantable Infusion Pump and Refill Kits are primarily used to treat chronic pain and severe spasticity. The device manuals currently include warnings related to the potential for improper injection, however, Medtronic is in the process of updating the labeling for the SynchroMedII and the SynchroMed EL pumps and associated refill kits with the information and patient management recommendations as outlined in the January 2011 letter.

Any adverse events with this or any other medical device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.