Medtronic Recalls Insulin Infusion Kits

May 19, 2004 -- A medical device maker is recalling an insulin infusion kit used by people with diabetes due to potentially dangerous problems.

Medtronic Inc. announced the nationwide recall yesterday after reports of problems with their Quick-Set Plus infusion models that can result in interrupted insulin flow to users. The company says these problems have resulted in a number of serious injuries, including some hospitalizations.

This recall applies to all Paradigm Quick-Set Plus infusion set models (MMT-359S6, MMT-359S9, MMT-359L6 and MMT-359L9) and lot numbers. It affects only the Quick-Set Plus infusion set; no other Medtronic devices or infusion sets are involved in this recall.

The infusion sets are used in conjunction with an insulin pump and deliver insulin from the pump to a patient's body.

The company is asking patients to contact its 24-hour help line at (800) MINIMED ((800) 646-4633) to exchange any unused Quick-Set Plus infusion sets for replacement sets available from Medtronic. If it is necessary to continue use of the Quick-Set Plus sets while replacement sets are en route, Medtronic is recommending that patients monitor their blood glucose levels frequently and be prepared to treat any elevated glucose levels that may occur with insulin injections.

People who use the devices are also being instructed to contact their healthcare professional in the event of excessively high or low glucose levels or with any questions about their care. Information regarding the exchange of Quick-Set Plus infusion sets is available at www.minimed.com/QSP.

Background on Recall of Insulin Infusion Kits

The voluntary recall is a follow-up to an action undertaken by Medtronic in March 2004 in response to an increased number of complaints related to the use of the Quick-Set Plus infusion set.

The complaints involved problems with bending of the small tube or cannula used to infuse insulin into the body or unintentional disconnection of the infusion set at the insertion site in the skin.

At that time, customers were provided with a Quick-Set Plus tips guide and offered replacement infusion sets upon request. The company also discontinued selling the Quick-Set Plus infusion sets in conjunction with this initial notification.

The FDA has classified the action as a Class I recall. A Class I recall is a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

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