FDA Issues Class 1 Recall for Medtronic Infusion Pumps

January 03, 2013

January 3, 2013

The United States Food and Drug Administration (FDA) recently issued a Class 1 recall for two Medtronic Infusion pumps- the SynchroMed II Implantable and the SynchroMed EL Implantable. A Class 1 recall indicates that there is a reasonable risk of serious adverse event or death with the use of the equipment. 

The recalled infusion pumps were found to stall intermittently or permanently which could prevent proper delivery of medication.

Model numbers affected by the recall are SynchroMed II models 8637-40 and 8637-20 and SynchroMed EL models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. These infusion pumps were manufactured from May 1998 through November 2012 and distributed from April 1999 through November 2012.

"Based on data from the firm's Implantable Systems Performance Registry, the overall failure rate of the SynchroMed II pump at 78 months post implant is 2.4% when used to dispense approved drugs, and 7.0% when used to dispense unapproved drugs," the FDA reported.

Medtronic advised healthcare professionals to avoid using compounded drugs, unapproved concentrations and formulations with these infusion pumps to minimize the occurrence of motor stall.

Improved infusion pump safety will lead to more effective patient care and reduced medication errors. To achieve these goals, it is essential to use infusion pump systems that are properly-serviced and in good working condition. AIV offers parts and services for most leading infusion pumps. Browse through AIV’s replacement parts and repair services at www.aiv-inc.com/iv-infusion-pump-replacement-parts.html.

To know more about recent medical device recalls, visit http://www.fda.gov/safety/recalls/default.htm.

About the Author

Laura Collier

Laura Collier

Laura Collier has a Bachelor’s Degree in Communications and a Master’s Degree in Business Administration from the University of North Florida. She is the Marketing Manager at AIV, Inc.

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