Medtronic Paradigm Reservoirs

Medtronic Paradigm Reservoirs

important medical device safety information

Medtronic Paradigm Reservoirs, 7/5/13
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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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