Medtronic Initiates Quick-Set Infusion Set Recall Due To Defects

Medtronic Quick Set Insulin Infusion Recall
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Medtronic has initiated a voluntary recall of Quick-set infusion sets. Only specific lots of the infusion sets which are used with MiniMed Paradigm insulin pumps are being recalled.

An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient. They need to be replaced by the patient every three days. Medtronic’s news release reports their recent discovery that approximately 2% of the affected Quick-set infusion sets may not work properly. There is the possibility that too much or too little insulin may be delivered by the device resulting in serious harm or even death.

The affected Medtronic Quick-set infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” Patients should discontinue using “Lot 8” Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package.

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Visit the Medtronic Diabetes website at www.medtronicdiabetes.com/lot8 to view the labels of “Lot 8” Quick-set infusion sets. Medtronic will exchange all affected products at no additional charge. For more information, patients may visit www.medtronicdiabetes.com/lot8 or call Medtronic’s dedicated information line 24 hours a day, seven days a week at 800-345-8139.

No other Medtronic devices or infusion sets are involved in this recall.

Adverse Event Reporting
Product problems should be reported to the Diabetes business at Medtronic by calling 800-345-8139 at any time. Adverse reactions or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Source
Medtronic News Room

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