Reservoir Recall

Product and Service Updates

 

Medtronic Paradigm® reservoir recall

Date 7-3-2013
Download important safety information for Paradigm® reservoir recall Download >

With safety as our top concern, we would like to make you aware that we are recalling certain manufacturing lots of Paradigm reservoirs that may have an increased potential for leaking. A leak in the reservoir may result in delivery of less insulin than intended, and if there is an insulin blockage in the infusion set, the pump may not alarm.

We will be contacting your patients and asking them to check the lot numbers on the reservoirs they have on hand, and to stop using reservoirs from the recalled lot numbers immediately.

The recall involves some of the manufacturing lots produced between October 2012 and February 2013, and in total, represents about 13% of the volume of reservoirs we make each year. Rest assured, we have corrected this problem and have placed additional testing and inspection steps into our manufacturing process. All Medtronic reservoirs other than those listed on the recall list found in the FAQ section are fine for your patients to use.

In order to make this as easy as possible, patients who received affected reservoirs from us in their last supply shipment will proactively receive a box of replacement reservoirs. In addition, we will provide replacement reservoirs to all patients who have affected lot numbers on hand at no additional cost. Please know that we have also shipped replacement reservoirs to diabetes camps across the country.

Because some patients get their pump supplies from direct mail pharmacies and other sources, we are sending this notice to all Paradigm users and asking them to reply back whether or not they have any reservoirs from the affected lots that need to be replaced. Once they reply to Medtronic, they may discard their affected reservoirs (there is no need to return them).

We deeply apologize for any disruption this may cause. Please know that we are doing all that we can to make this process as easy as possible for your patients.

Reservoir Box Example Individual Reservoir Package Example
Reservoir Box Example Individual Reservoir Package Example
FAQs
Q:
Why is Medtronic recalling certain manufacturing lots of model MMT-326A and MMT-332A insulin reservoirs? >
A:
We are recalling these reservoirs due to the potential that reservoirs from these lots may be at increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if you have a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not alarm to notify you.
Q:
Which lot numbers are being recalled? >
A:
We have provided an online tool at medtronicdiabetes.force.com/medtronicdmcom/checklots where you can enter the lot numbers from the reservoirs you have on hand to see if they are part of this recall. In addition, below is the complete list of lot numbers for MMT-326A and MMT-332A that are being recalled:

H8416432 H8461538 H8489386 H8512826 H8420977
H8463297 H8491921 H8515317 H8422490 H8464121
H8492449 H8517079 H8424676 H8467888 H8494645
H8521052 H8437486 H8469703 H8496561 H8539013
H8441420 H8471745 H8500423 H8541843 H8442973
H8473106 H8500472 H8584244 H8451531 H8473271
H8503372 H8627745 H8452933 H8476270 H8503728
H8603292 H8455959 H8478398 H8509305 H8604958
H8457716 H8485398 H8510440 H8635301 H8459557
H8486688 H8512566

We recommend you check all reservoirs you have on hand against this list (or use the online verification tool on our website).
Q:
How do I locate the lot number? >
A:
The lot numbers are located on the side panel of the reservoir box, as well as on the side of the individual reservoir packaging. The lot number starts with an “H” and is followed by a 7-digit number. For example, H8486688 (see visual reference below).

Reservoir Box Example Individual Reservoir Package Example
Reservoir Box Example Individual Reservoir Package Example
Q:
Has Medtronic stopped shipping affected lots of reservoirs? >
A:
Yes, Medtronic has stopped shipping reservoirs from the affected lots.
Q:
Does this recall affect all Medtronic reservoirs? >
A:
No. Only the reservoirs with the lot numbers listed above are affected by the recall. All Medtronic reservoirs other than those listed above are fine to use.

This recall affects approximately 13% of the volume of reservoirs Medtronic manufactures in a year. We are being cautious and recalling certain reservoir lots that were manufactured between October 2012 and February 2013 that may have an increased potential for leaking. Rest assured, we've corrected this problem and have placed additional testing and inspection steps into our manufacturing process.
Q:
What solution is Medtronic providing to its customers? >
A:
Medtronic will replace all affected reservoirs that customers have on hand at no cost, and will make this process as easy as possible.
Q:
Is Medtronic committed to product quality? >
A:
Absolutely! At Medtronic, making quality products that you can trust is our top priority. We are committed to improving our products and to communicating about potential issues when they arise. We will continue to communicate as often as needed because we know that is what you expect from Medtronic as your partner in diabetes care. We believe doing so makes our customers the safest, most educated and informed patients.
Q:
Has Medtronic notified my healthcare professional? >
A:
Yes. Medtronic has notified healthcare professionals who prescribe Medtronic insulin pumps, as well as clinicians who train patients on our product.
Q:
May I wait a few days to change my reservoir? I just started using a reservoir from the affected lot and have a full insulin reservoir. I would prefer to use my insulin so I don't waste it. >
A:
You should stop using your reservoir from an affected lot right away, even if you need to discard some insulin. Please know we are making this recommendation for your safety. We recognize there will be some insulin waste and deeply apologize for this situation.
Q:
Should I return my affected reservoirs to Medtronic? >
A:
No, you do not need to return the affected reservoirs. Any reservoirs included in this recall should be disposed of immediately. Please remember to follow your local governmental regulations for disposal of sharps.
Q:
I have reservoirs from the affected lots. How do I get replacements for these reservoirs? >
A:
Use one of the following methods to notify us:
Q:
I've notified Medtronic that I need replacement reservoirs, when will I receive them? >
A:
Replacement reservoirs will be shipped as soon as possible via UPS. If you have an immediate need, enter your information into the online form on our website, www.medtronicdiabetes.com/support/product-updates.
Q:
Medtronic indicates that it fixed a manufacturing process related to the production of reservoir stoppers. What is a stopper? >
A:
The reservoir stopper is pushed by the piston to deliver insulin once it is inside the pump. It is the part with two O-rings that is left in the reservoir barrel after you have removed the plunger during the reservoir fill process.