Frequently Asked Questions

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

Individual Package Label
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.
Why do Paradigm Quick-set infusion sets have vents?
All Paradigm infusion sets have vents incorporated into the tubing connector. The vents allow air, but not fluid, to pass in and out of the reservoir compartment. Venting is necessary to equalize the pressure in the reservoir compartment of the insulin pump with the surrounding atmosphere.
What is clogging the vents in a small percentage of "Lot 8" Quick-set infusion sets?
A lubricant clogged the vents on a small percentage of "Lot 8" Quick-set infusion sets. The lubricant has been eliminated from the manufacturing process, so you can rest assured this is no longer a problem. All Medtronic infusion sets other than "Lot 8" Quick-set infusion sets are fine.
What happens if the vents are clogged in "Lot 8" Quick-set infusion sets?
If vents are clogged, there is a potential for too much or too little insulin to be delivered.
In what circumstance could too much insulin be delivered using a "Lot 8" Quick-set infusion set?
When an infusion set does not vent properly, a rapid increase in altitude could cause too much insulin to be delivered. Examples of this include when an airplane is taking off, and traveling from sea level to a higher elevation, such as when driving up a mountain. A significant over delivery of insulin may not be detected until after it has occurred. This could cause severe low blood glucose and would require immediate attention and treatment. Do not fly in an airplane or engage in any activity that involves a significant increase in altitude if using "Lot 8" Quick-set infusion sets.
In what circumstances would too little insulin to be delivered using a "Lot 8" Quick-set infusion set?
When an infusion set does not vent properly, even at stable altitude or stable air pressure, insulin delivery can be interrupted. This happens because the priming process may build up air pressure in the reservoir compartment. The insulin pump could appear to be working properly when it is not. This might result in too little insulin being delivered, which could cause high blood glucose to occur. As always with insulin pump therapy, any interruption in insulin delivery can be detected through frequent blood glucose monitoring.
How can I test to see if I have received too much or too little insulin from a "Lot 8" Quick-set infusion set?
The best indicator to determine if your blood glucose levels are within normal range is by frequent testing of your blood glucose (BG) using a BG meter.
Is Medtronic contacting my doctor about this recall?
Yes. We are notifying healthcare professionals who prescribe Quick-set infusion sets, as well as clinicians who train patients on our product.
Why did you notify my doctor about the recall before me?
We informed all the doctors in our database in advance to ensure they would be prepared to address your healthcare concerns.
Why did I receive two notifications?
Any time there is a FDA recall, the obligation is to notify anyone who may have received affected products and it frequently results in duplicate notifications. For example, you may have received the same product from two different companies and they each requested that you receive a notification. We apologize if this was confusing.

Please use the notification materials from the company who ships your current infusion set supplies. You can look at the label on the shipping box to find out who sent it to you.
What is in the package you are sending Medtronic customers to notify them about the recall?
We have mailed all "Lot 8" Quick-set infusion set users a package containing:
  • A letter
  • A pre-paid UPS return label
  • A reply card
In addition, Quick-set users identified as having placed a recent order have also been sent one initial box of replacement Quick-set infusion sets.
Can I just throw away my unused "Lot 8" Quick-set infusion sets? Why do I have to notify Medtronic?
No, please do not throw them away. We need to confirm that you've received this notification and ask that you return your unused "Lot 8" Quick-set infusion sets to us. Please use this form to notify us of your unused "Lot 8" Quick-set infusion sets.
What if I don't have any unused "Lot 8" Quick-set infusion sets?
Please take a moment to notify us even if you don't have any "Lot 8" Quick-set infusion sets to return. We need to confirm that you've received this notification because your safety is our top priority.
I heard you sent some customers a box of replacement Quick-set infusion sets. Why didn't I get one?
Customers who have ordered Quick-set infusion sets within the last six months received an initial replacement box. If you have unused "Lot 8" Quick-set infusion sets, you can receive replacement infusion sets as well. Simply complete the notification form.
May I wait a few days to change my infusion set? I just started using a "Lot 8" Quick-set infusion set and have a full insulin reservoir. I would prefer to use my insulin so I don't waste it.
We recommend that you stop using your "Lot 8" Quick-set infusion set right away, even if you need to discard some insulin. Please know that we are making this recommendation for your safety. We recognize that there will be some insulin waste and deeply apologize for this situation.
I didn't receive a package from Medtronic, what should I do?
We are mailing packages to all customers affected by this recall in stages, so your package is probably on its way. You may want to wait a few days until the package arrives, or you can follow our notification process. If you have any unused "Lot 8" Quick-set infusion sets to return to us, as part of Step 4 on the notification form, be sure to check the box to indicate that you need a pre-paid UPS return label. This will be provided to you when you receive your replacement Quick-set infusion sets.

If you received your Quick-set infusion sets through another supplier, then you will need to contact them for your replacement products.
I have opened boxes with unused "Lot 8" Quick-set infusion sets. May I return those as well for replacement?
Yes, we are replacing all unused "Lot 8" Quick-set infusion sets. It's okay if you have opened the box but we cannot replace individual infusion sets that have been opened.
How do I return my unused "Lot 8" Quick-set infusion sets?
Step 1: Complete the notification form.
Step 2: Place your unused "Lot 8" Quick-set infusion sets in a box.
Step 3: Secure the pre-paid UPS return label provided to you from Medtronic on the outside of the box.
Step 4: Ship the box—use one of the following methods to reach UPS

  • Find a UPS center near you (nearest location).
  • Call 1.800.742.5877 to schedule a pick up. Let UPS know you have a pre-printed return label.
Is Medtronic providing me with a box for free to return "Lot 8" Quick-set infusion sets?
No. Since we don't know how many unused "Lot 8" Quick-set infusion sets you have, we are not able to estimate the size of a box you need. Instead we provided a pre-paid UPS return label for you to place on the outside of the box.

Feel free to use any shipping box you may have on hand that will hold all of your unused "Lot 8" Quick-set infusion sets.
Once I return my unused "Lot 8" Quick-set infusion sets to you, how will I know if Medtronic received them?
Make a note of the tracking number on the pre-paid UPS return label that we provided to you. The tracking number can be used to track the status of your shipment. The tracking number is located under the phrase "UPS 2ND DAY AIR."
The pre-paid UPS return label states that it is only for 1 pound. What if my unused "Lot 8" Quick-set infusion sets weigh more than that?
The pre-paid UPS return label was pre-printed so we needed to put a weight on the label. However we have also made arrangements with UPS to allow you to ship up to 70 pounds back to us as long as you use the return label provided.
Where do I get a pre-paid return label? (For example: I lost it or never received a package)
A pre-paid return label is provided in the package we sent to all Medtronic customers. If, for some reason, it wasn't included, you can order a new pre-paid UPS return label when you complete the notification form. As part of Step 4 in this process, be sure to check the box to indicate that you need a pre-paid return label. You will receive a new label with your shipment of replacement Quick-set infusion sets.
I don't want to wait for a pre-paid return label—just give me the address.
I'm sorry, a pre-paid UPS return label is required for us to track unused "Lot 8" Quick-set infusion sets that are being returned to our company. This will allow us to update your Medtronic account appropriately.
Will I have to pay to have these infusion sets returned to Medtronic?
No. The label we are providing to you is pre-paid through UPS. All you have to do is place your unused "Lot 8" Quick-set infusion sets in a box and ship them to us. We will pay for the shipping charges to send the infusion sets back.
What if I have an open infusion set, should I return that too?
Any used or open infusion sets should be discarded properly into a Sharps container and NOT returned to us. This will prevent needle injuries.
Do I need to be home to receive my package?
No. Your package does not require a signature upon delivery.
Now that I've notified Medtronic that I need replacement infusion sets, can I find out when I will receive them?
Please call our automated system at 1.800.345.8139 and select option 3 to hear the status of your next replacement box. You will be asked for some personal information to verify who you are on this system, such as your date of birth and zip code.
I have multiple boxes of infusion sets to return. Will I receive my replacement infusion sets all at once?
We're sorry. In order to serve all our customers during this recall, we are shipping replacement infusion sets at a rate of one box every three weeks. We deeply apologize for the inconvenience—our first priority is to make sure everyone has the infusion sets they need.
How long will it take to for me to get all of my Quick-set infusion sets replaced?
Our goal is to ensure that you receive regular product shipments in order to stay on insulin pump therapy. We will replace your product progressively as our inventory allows.
I don't buy my products directly from Medtronic, I buy them through a supplier. Do I return my unused "Lot 8" Quick-set infusion sets to Medtronic?
No, your supplier will contact you with paperwork so you can return your unused "Lot 8" Quick-set infusion sets to them. If you have their phone number, you may also give them a call to start this process. You should not return these products to Medtronic.
Why did I receive two notifications?
Any time there is a FDA recall, the obligation is to notify anyone who may have received affected products and it frequently results in duplicate notifications. For example, you may have received the same product from two different companies and they each requested that you receive a notification. We apologize if this was confusing.

Please use the notification materials from the company who ships your current infusion set supplies. You can look at the label on the shipping box to find out who sent it to you.
I would prefer a refund as opposed to a replacement infusion set for my unused "Lot 8" Quick-set infusion set. Is this possible?
Yes, we can provide you with a refund for the unused "Lot 8" Quick-set infusion sets you return as long as you purchased them directly from us. Please note refunds are credited to the person or insurance company who paid the original claim. For example if you have 100% insurance coverage, the refund will be credited to your insurance company.
Will I or my insurance be charged for replacement Quick-set infusion sets?
No. We are providing these replacement Quick-set infusion sets at no additional charge. If you use the pre-paid UPS return label provided, Medtronic will cover also the cost of shipping.
How will this recall affect my next supply order?
Due to limited inventory, please be aware when you place your next supply order, your Quick-set infusion sets will be sent at a rate of one box at a time based on your personal utilization rate and our inventory levels. Please note, if your supplies are covered through insurance, you will only be responsible for one co-pay. If you notice something different, please contact our patient financial services department at 1.800.646.4633 and select option 4.