TRENDS & TECHNOLOGY
Abstract
DA Recalls Implantable Infusion Pumps and Refill Kits
FDA issued a class I recall of Medtronic’s SynchroMed II and SynchroMed EL implantable infusion pumps and refill kits, used for the long-term infusion of pain, cancer treatment and anti-spasm medications. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death. These pumps and refill kits have been recalled because pocket fills — the unintended injection of drugs or fluids into the tissue under the skin at the pump pocket site — have occurred and may result in patient harm, serious injury, and/or death due to drug overdose or underdose. The recalled products were manufactured from June 1998 to January 2003 and distributed from April 1999 to January 2011.
