Important medical device safety information


Medtronic Paradigm Reservoirs


Download important safety information for Paradigm® Reservoirs Download

7/5/13

Because the safety of our customers is our top priority, we are voluntarily recalling certain manufacturing lots of part number MMT-326A (1.8 mL) and MMT-332A (3.0 mL) reservoirs used with our Paradigm insulin pumps. We are recalling these reservoirs due to the potential that reservoirs from these lot numbers 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.

Our investigation has indicated that this increased potential for reservoir leakage was caused by abnormal wear on a manufacturing tool involved in the production of reservoir stoppers. We are recalling all lots of reservoirs that contain any stoppers from that tool. We have corrected this problem and have placed additional testing and inspection steps into our manufacturing process.

We are instructing all customers not to use reservoirs from these lot numbers and are providing replacement product at no additional charge.

We are asking customers to verify the lot numbers of the reservoirs they have on hand using our online tool. If the tool determines that any of your lot numbers are affected, further instructions will be provided within the tool.

For any further questions about this issue, please contact us at 1.866.450.0890 Monday through Friday, 8AM – 6 PM Central Time.

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.


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Frequently asked questions


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.

We have provided an online tool 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:

H8416432H8461538H8489386H8512826
H8420977H8463297H8491921H8515317
H8422490H8464121H8492449H8517079
H8424676H8467888H8494645H8521052
H8437486H8469703H8496561H8539013
H8441420H8471745H8500423H8541843
H8442973H8473106H8500472H8584244
H8451531H8473271H8503372H8603292
H8452933H8476270H8503728H8604958
H8455959H8478398H8509305H8627745
H8457716H8485398H8510440H8635301
H8459557H8486688H8512566

We recommend you check all reservoirs you have on hand against this list (or use the online verification tool).

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
ExampleIndividual Reservoir
Package Example
Yes, Medtronic has stopped shipping reservoirs from the affected lots.

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.

Medtronic will replace all affected reservoirs that customers have on hand at no cost, and will make this process as easy as possible.
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.
Yes. Medtronic has notified healthcare professionals who prescribe Medtronic insulin pumps, as well as clinicians who train patients on our product.
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.
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.

Use one of the following methods to notify us:

OR

  • Mail the reply card provided
Replacement reservoirs will be shipped as soon as possible via UPS.
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.