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5/19/2004

Insulin Infusion Sets Recalled by Medtronic

Cheryl A. Thompson

Medtronic Inc. announced Tuesday that its Diabetes division is recalling Quick-set Plus infusion sets because they may interrupt flow from the Paradigm insulin infusion pump. Patients with the infusion sets are being asked to contact the company immediately to arrange an exchange for alternate sets.

According to the company, the Food and Drug Administration has classified this recall as Class I, meaning there is a "reasonable probability" that patients could suffer serious adverse health consequences or die from using the infusion set. Medtronic reported that some patients have had injuries serious enough to require hospitalization.

The company said that, in March, it initially responded to complaints about Quick-set Plus models MMT-359S6, MMT-359S9, MMT-359L6, and MMT-359L9 by distributing a "Quick-set Plus tips guide" and offering to replace the infusion sets on request. These complaints described bending of the infusion set or unintentional disconnection at the insertion site. Sales of the infusion sets ceased at that time.

Until the replacement infusion sets arrive, the company advised, patients should frequently monitor their blood glucose concentration, be prepared to self-administer insulin if the Quick-set interrupts flow from the infusion pump, and contact a health care professional if their blood glucose level is excessively high or low or they have questions about diabetes management.

More information about the recall—instructions on exchanging the product, the March 15 letter to users, and answers to frequently asked questions—is available online or at 800-646-4633.

The Quick-set Plus product line was launched in November 2003.