Infusion Pump Improvement Initiative

Over the past several years, significant safety issues related to infusion pumps have come to FDA’s attention.

From 2005 through 2009, FDA received approximately 56,000 reports of adverse events associated with the use of infusion pumps, including numerous injuries and deaths. During this time period, 87 infusion pump recalls were conducted by firms to address identified safety concerns. 70 of these recalls were designated as Class II, a category that applies when the use of the recalled device may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. 14 recalls were Class I – situations in which there is a reasonable probability that use of the recalled device will cause serious adverse health consequences or death. These adverse event reports and device recalls have not been isolated to a specific manufacturer, type of infusion pump, or use environment; rather, they have occurred across the board. Download PDF Attachment