Medtronic Infusion Pumps Class I Recall

October 03, 2011

October 3, 2011

This week, the Food and Drug Administration (FDA) released an order to recall all Medtronic SynchroMed II infusion pumps, models 8637-20 and 8637-40distributed between May 2004 and July 2011. The problem started with the pump batteries producing a film which reduced the performance of the pump. 

The SynchroMed II pumps are used with infusion systems to deploy various medication for chronic pain, severe spasticity and primary or metastatic cancers. It was reported that Medtronic had already warned the public about the problem last July 2009, however, only sent out correction letters to clinicians last July 2011.

“There is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death”, the FDA reports. Patients are advised to consult with their physicians if symptoms return or if the device alarms.

AIV supports many of the leading infusion pump models. Visit the link to view a full listing of available parts and repair services.

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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