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U.S. Department of Health and Human Services

Medical Devices

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Medtronic MiniMed Paradigm Quick-Set Infusion Sets

Recall Class:Class I
Date Recall
Initiated:		June 29, 2009
Product:

Paradigm Quick-Set Infusion Sets, Models MMT-396, MMT-397, MMT-398, and MMT-399 (with lot numbers beginning with “8,” for example 8XXXXXX)

The lot number is clearly marked on both the product label, and on each individual infusion set package.

Only “Lot 8” Paradigm Quick-set infusion sets are affected by this recall.

These devices were manufactured and distributed from December 1, 2007 through June 18, 2009.

Use:An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient.
Recalling Firm:Medtronic MiniMed
18000 Devonshire Street
Northridge, California 91325
Reason for Recall:These infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may cause serious injury or death.
Public Contact:

The company may be contacted anytime, 24 hours a day, seven days a week.

Physicians:

  • may contact a Medtronic Diabetes medical officer at 1-818-576-4211
  • report product problems at 1-800-345-8139 

Patients/Customers:

  • may contact the company at 1-800-345-8139 

See additional information under Useful Links below.

FDA District:Los Angeles
FDA Comments:

Patients should stop using “Lot 8” Quick-set infusion sets.

From July 6-9, 2009, the company sent letters to healthcare professionals, distributors, active customers and patients (sets purchased after January 1, 2009) and inactive customers (sets purchased before January 1, 2009). Active patients and customers received one box of replacement sets with their letters. 

Letters to patients and customers included instructions to:

  • stop using the recalled infusion sets.
  • notify the company by any of the following methods:
    • complete and mail the enclosed reply cards
    • visit their website
    • call the company
  • confirm receipt of the recall notice.
  • identify any unused sets to return.   
  • order replacement sets.

Letters to distributors who purchased the affected devices included directions to:

  • stop distributing the affected product.
  • notify all patients they have provided infusion sets for or provide patient names and addresses to the firm so that Medtronic MiniMed can inform the patients.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Links:

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