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U.S. Department of Health and Human Services

Safety

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Medtronic Paradigm Quick-Set Infusion Sets

Audience: Diabetes healthcare professionals, patients

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. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected 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. Customers are being asked to return any affected infusion sets to the company.

[07/13/2009 - Press Release - Medtronic]

[7/21/2009- Recall Notice]