Home
 »  News
 »  Medtronic Issues Recall of Specific Lots of Paradigm Quick-Set Infusion Sets
Diabetes1 Headlines

Medtronic Issues Recall of Specific Lots of Paradigm Quick-Set Infusion Sets

Printer Friendly Version     Email this Article     Links/Reprints

Insulin Pump with Infusion Set

Medtronic Issues Recall of Specific Lots of Paradigm Quick-Set Infusion Sets

July 16, 2009

This press release is an announcement submitted by the FDA, and was not written by Body1.

16 July 2009

Medtronic, Inc. (NYSE:MDT) said today that it has initiated a recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number "8." Medtronic recently discovered that approximately two percent of "Lot 8" Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly. The affected 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 lead to serious injury or death.

Patients should discontinue using "Lot 8" Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Visit the Medtronic Diabetes website at www.medtronicdiabetes.com/lot8  to view the labels of "Lot 8" Quick-set infusion sets. Customers are being asked to return any affected infusion sets to the company. 
Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge.

"Lot 8" Quick-set infusion sets were distributed in the United States, and in limited quantities in a small number of countries outside of the United States. The list of countries affected by this recall is available at www.medtronicdiabetes.com/lot8 or by contacting any Medtronic country office.  No other Medtronic devices or infusion sets are involved in this recall.

"Our commitment to patient safety is our top priority," said Chris O’Connell, president of the Diabetes business unit and senior vice president at Medtronic. "We are focused on ensuring that patients and clinicians have up-to-date information and access to replacement infusion sets. We are working closely with the FDA, and our goal is to make this product exchange as timely and as easy as possible for patients."

Adverse Event Reporting
Product problems should be reported to the Diabetes business at Medtronic by calling
800-345-8139 at any time. Adverse reactions or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Information for Patients
Medtronic will exchange all affected products at no additional charge.  For more information, patients may visit www.medtronicdiabetes.com/lot8 or call Medtronic’s dedicated information line 24 hours a day, seven days a week at 800-345-8139.

About the Diabetes Business at Medtronic
The Diabetes business at Medtronic (www.medtronicdiabetes.com) is the world leader in advanced diabetes management solutions, including integrated diabetes management systems, insulin pump therapy, continuous glucose monitoring systems and therapy management software, as well as world-class, 24/7 expert consumer and professional service and support.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology, alleviating pain, restoring health and extending life for millions of people around the world.

Previous Stories

IDF Statement on Studies Suggesting Possible Insulin Glargine Cancer Link

FDA Issues Public Health Advisory Regarding Levemir Insulin

Part Two – Protein is Not “Free” - How to Tier Insulin for Balanced Dosing

more Feature Stories

Comments

  • Add Comment

  • RSS
    From the BLOGS
    My Third Left "Nipple"
    Comment By FatCatAnna
    more
    Comment
    more Blogs
    Medication
    By FatCatAnna

    Posted: Mar 17, 2017
     Thanks for that Andre77 ... though in this area where you've posted "Type 1 Diabetes" - we already know we've got diabetes (50+ years for me).   DiabetesUK has a pretty good description of ...

    more more Forums Create a Topic
    Youth Diabetes: A Teacher's Perspective
    A young middle school teacher who talks about the impact obesity has had ...
    more more Featured Videos
    Cost Savings Tool
    Do you know the annual cost of managing your diabetes? Would you like to find ways to reduce your costs? Calculate your total budget and identify ways to save money. You can do this in just a few minutes by entering facts about the products you use. This quick analysis will provide you with a comprehensive overview of both spending and potential savings.

    Cost Savings Tool
    Monitor Comparison Tools
    Blood glucose monitors offer an easy way to test your blood sugar at home or on the go. Use this comparison tool as a guide to learn more about the features and benefits of your current monitor or to find a new one.
    Handheld Monitor Comparison
    Continuous Glucose Monitor Comparison
    Advanced BMI Calculator
    Ever wonder if you are at a healthy weight? Then enter your height and weight in our advanced Body Mass Index (BMI) calculator. This tool provides you with two important numbers reflecting the estimated impact of your present body weight and shape upon your overall health.
    Advanced BMI Calculator
    more Care Tools
     
    Dr. Wayne Caputo

    Dr. Wayne Caputo:

    Simplifying Treatment of Diabetic Ulcers
      more
      more Heroes
      nominate a Hero
      Hero policy
    Home | About Us | Press | Make a Suggestion | Content Syndication | Terms of Service | Editorial Policy | Privacy Policy
    Last updated: Jun 24, 2017  © 2017 Body1 All rights reserved.