Medtronic Recalls Insulin Infusion SetsJul 10, 2009 | Parker Waichman LLP
Medtronic Inc. is recalling some of its Quick-set insulin infusion sets that are used with MiniMed Paradigm insulin pumps. According to a Medtronic statement released today, the Quick-set insulin infusion sets may not vent air pressure properly, causing delivery of improper amounts of insulin and the potential for serious injury or death.
An insulin 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. Medtronic said it recently discovered that approximately two percent of “Lot 8” Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly.
The Quick-set infusion sets involved in this recall bear 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.
“Lot 8” Quick-set infusion sets were distributed in the United States, and in limited quantities in a small number of countries outside of the United States. The list of countries affected by this recall is available at www.medtronicdiabetes.com/lot8 or by contacting any Medtronic country office. No other Medtronic devices or infusion sets are involved in this recall.
Customers are being asked to return any affected infusion sets to the company. Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge. According a report in The Wall Street Journal, Medtronic has mailed out notification letters to customers, as well as one million replacement sets, which represent a 30-day supply.