Medtronic Paradigm Quick-Set Infusion Sets
MedSun: Newsletter #39, August 2009

FDA Recall Notice

Medtronic, Inc. and FDA notified healthcare professionals and patients of a recall of Quick-set infusion sets that are used with MiniMed Paradigm insulin pumps because the affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death.

Additional Information:

FDA MedWatch Safety Alert. Medtronic Paradigm Quick-Set Infusion Sets. July 13, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171686.htm

Medtronic Press Release. Medtronic Voluntarily Recalls Specific Lots of Paradigm® Quick-Set® Infusion Sets In The United States. July 21, 2009.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm171588.htm


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