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U.S. Department of Health and Human Services

Medical Devices

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MiniMed Paradigm Quick-set Plus Insulin Administration Set

Class I Recall
Date Recall Initiated:
March 2, 2004
Product:
MiniMed Paradigm Quick-set Infusion Sets.
Models MMT-359S6,
MMT-359S9,
MMT-359L6
MMT-359L9
Use:
Administration sets are used to administer fluids from a container to a patient. Specifically, this device is an insulin administration set. Insulin administration sets are thin, plastic tubing, which deliver insulin from the insulin infusion pump to the body. At the end of the tubing is a soft, flexible cannula, which is a small, tapered tube. With the help of an insertion device, the cannula is inserted under the skin. One insulin infusion set is intended to be used for 2 or 3 days and then disposed of.
Recalling Firm:
Medtronic MiniMed
18000 Devonshire St.
Northridge, California 91325-1219
Reason for Recall:
There have been complaints of bent cannulas, occlusions within the tubing, leaking at the insertion site, and accidental dislodging of the infusion set while removing the insertion device. Additionally, there have been reports of adhesive failure, which causes the device to detach from the skin. These problems have resulted in the interruption of insulin flow to the patients.
Public Contact:
Mark Faillace
Sr. Director, Device Regulatory Affairs and QA
818-576-5616
FDA District:
Los Angeles
FDA Comment:
Patients should discontinue use of the Paradigm Quick-set Plus infusion sets as soon as they can obtain replacement units. The firm will provide free replacements via overnight delivery. Patients should call the 24-hour Help Line at 800-646-4633 (800 MINIMED) or contact the firm to exchange any unused infusion sets. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
  For additional information on this product recall, see the nearby links.