MEDTRONIC RECALLS QUICK-SET PLUS INFUSION SETS
The following information is from Medtronic, Inc.. Contact the company for a copy of any referenced enclosures.
MEDTRONIC RECALLS QUICK-SET ® PLUS INFUSION SETS
NORTHRIDGE, Calif., May 18, 2004 - Medtronic, Inc. today announced that its Diabetes division began notifying diabetic patients, healthcare professionals and distributors that it is conducting a nationwide recall of Quick-set ® Plus infusion sets because of problems that can interrupt insulin flow to diabetics who use them. These problems have resulted in a number of serious injuries, including some hospitalizations.
The company is asking patients to contact its 24-Hour Help Line at (800) MINIMED ( 1-800-646-4633 ) to exchange any unused Quick-set Plus infusion sets for replacement sets available currently from Medtronic. In the event that it is necessary to continue use of the Quick-set Plus while replacement sets are in transit, Medtronic is recommending that patients monitor their blood glucose levels frequently and be prepared to treat any elevated glucose levels that may occur with injections. Patients 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 .
This recall applies to all Paradigm Quick-Set Plus models (MMT-359S6, MMT-359S9, MMT-359L6 and MMT-359L9) and lot numbers. This action affects only the Quick-set Plus infusion set; no other Medtronic devices or infusion sets are involved in this recall.
This notification is a follow-up to a voluntary action undertaken by the company in March 2004 in response to an increased number of complaints related to the use of the Quick-set Plus infusion set, which delivers insulin from an infusion pump to a patient's body. The complaints involved problems with bending of the infusion set's cannula or unintentional disconnection of the set at the insertion site 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 U.S. Food and Drug Administration (FDA) has classified this voluntary action as a Class I recall. The FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Medtronic's Diabetes business (www.minimed.com ) is the world leader in insulin pump therapy and continuous glucose monitoring. The company's products include external insulin pumps, related disposable products, and a continuous glucose monitoring system. Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis , is the world's leading medical technology company, providing lifelong solutions for people with chronic disease.
EDITOR'S NOTE: Detailed information about diabetes, insulin pump therapy and the Paradigm 512 pump and Paradigm Link system is available by accessing Medtronic's online newsroom at www.medtronic.com/newsroom. Any statements made about the company's anticipated regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report on Form 10-K for the year ended April 25, 2003. Actual results may differ materially from anticipated results.