Medtronic Quick Set Problems

In July 2009 the FDA announced a Medtronic Paradigm recall for an estimated 3 million infusion sets used with the Medtronic insulin pump. The Medtronic Quick Set Recall of the infusion sets followed concerns that approximately 60,000 Quick-Set infusion sets used with the Medtronic Paradigm insulin pumps may be defective. The following are questions and answers from Medtronic regarding the Medtronic Quick Set problems.

Why is Medtronic recalling “Lot 8” Quick-set infusion sets?

We recently identified that a small percentage of “Lot 8” Quick-set infusion sets used with MiniMed Paradigm insulin pumps may not work properly—some of these infusion sets do not allow the insulin pump to vent. This can potentially cause too much or too little insulin to be delivered and may lead to serious injury or death.

Are the vents fixed in Quick-set infusion sets? Has Medtronic stopped shipping “Lot 8” Quick-set infusion sets?

Yes. The venting issue has been fixed and we are no longer shipping “Lot 8” Quick-set infusion sets.

Are replacement Quick-set infusion sets safe to use?

Yes! With the venting issue fixed, you can feel perfectly comfortable using your replacement infusion sets.

What solution is Medtronic providing to its customers?

Medtronic is exchanging any unused “Lot 8” Quick-set infusion sets for customers who have received “Lot 8” Quick-set infusion sets at no additional charge.

Does this recall affect all Quick-set infusion sets?

No. Only Paradigm® Quick-set® infusion sets that have lot numbers starting with the number “8” with the following reference numbers are affected by this recall: MMT-396, MMT-397, MMT-398 and MMT-399. Rest assured, all Medtronic infusion sets other than “Lot 8” Paradigm Quick-set infusion set are fine to use.

How do I find the lot number “8” on my “Lot 8” Quick-set infusion set?

Box Label

Medtronic Quick Set

Individual Package Label

Medtronic Lot 8

How did Medtronic discover this situation?

As an organization, we investigate and track all customer complaints. It came to our attention that an infusion set was not working properly. After testing it, we discovered that the infusion set had clogged vents. Our investigation revealed that a lubricant clogged the vents in a small percentage of “Lot 8” Quick-set infusion sets. To solve this situation, the lubricant was eliminated from the manufacturing process.

When did Medtronic change its manufacturing processes?

In December 2007, a small amount of lubricant was added to the manufacturing process in order to make a smoother connection between the infusion set and insulin reservoir.

As of June 19, 2009, we are no longer shipping “Lot 8” Quick-set infusion sets.

Which Medtronic infusion sets can I use with my MiniMed Paradigm insulin pump?

Only “Lot 8” Paradigm Quick-set infusion sets are affected by this recall. This means that any other Medtronic infusion set may be used to manage your diabetes. This includes Quick-set infusion sets other than “Lot 8,” Silhouette® infusion sets, Sof-set® infusion sets, Sure-T® infusion sets and Polyfin® infusion sets for use with MiniMed Paradigm insulin pumps. To learn more about our infusion set options, click here. Any change to a new type of infusion set should be done in consultation with your healthcare provider.

Which countries outside the United States are affected by this recall?

Very limited quantities of “Lot 8” Quick-set infusion sets have been distributed outside of the U.S. These countries include: Bahamas, Bermuda, Brazil, Canada, Ecuador, El Salvador, Germany, Kuwait, Mexico, Paraguay, Turkey and the UK.

What can Canadian customers expect?

Canadian customers who have received “Lot 8” Quick-set infusion sets from Medtronic Diabetes will be contacted.

Canadian customers who have questions or concerns should call Canada’s Customer Service Line at 1.800.284.4416 for more information.

How do I know a recall like this won’t happen again?

Product quality is extremely important to our company and we know it is important to you as well. I want to assure you that we have a strong quality system in place. We can promise you that we always take quality and safety very seriously. This commitment starts the moment you receive your product and continues throughout your partnership with Medtronic.

If you or a loved one has been affected by the Medtronic Quick Set recall please contact us for a free no-obligation consultation and case review. A Medtronic recall attorney can go over your legal rights and options and evaluate any potential claims you may have. You may be entitled to compensation and we can help.