Certain Medtronic MiniMed Insulin Infusion Sets Recalled

Medtronic MiniMed is recalling the company's Paradigm Quick-set Plus insulin infusion sets because of problems that can interrupt insulin flow to diabetic patients who use them. These problems have included bent cannulas, occlusions in the tubing, leaking at the insertion site, and accidental dislodging of the infusion set while removing the insertion device. A number of serious injuries have occurred as a result, including some hospitalizations.

This recall covers all Paradigm Quick-set Plus models (MMT-359S6, MMT-359S9, MMT-359L6 and MMT-359L9) and lot numbers. Patients who have any of these sets should contact the company at (800) MINIMED to get free replacements by overnight delivery. They should stop using the recalled sets as soon as they get the replacements.

If patients need to continue to use the Quick-set Plus sets while waiting for replacements, Medtronic is recommending that they monitor their blood glucose levels frequently, and be prepared to inject insulin if necessary. Patients should also contact their healthcare provider if they experience excessively high or low glucose levels.

Additional Information:

FDA MedWatch Safety Alert -- Paradigm Quick-set Plus Insulin Administration Sets
http://www.fda.gov/oc/po/firmrecalls/medtronic05_04.html

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News & Politics

Tags:

• Medtronic
• MiniMed
• Insulin
• Infusion
• Recall
• FDA
• Patient
• Safety