Leakage risk forces recall of Medtronic insulin pump reservoirs

Medtronic voluntarily recalling certain reservoirs used with the company’s Paradigm insulin pumps due to safety concerns.
Last week, the medical technology firm wrote to customers to warn that certain manufacturing lots of model MMT-326A (1.8 mL) and MMT-332A (3.0 mL) insulin reservoirs may be at increased risk for leaking.
A leak in the reservoir could cause less insulin to be delivered than intended, resulting in high blood sugar levels, and if an insulin blockage occurs in the infusion set, the pump may not alarm to notify the user, Medtronic explained.
For people with diabetes, under-delivery of insulin can lead to the development of a dangerous complication called diabetic ketoacidosis.
An investigation by Medtronic indicated the increased potential for reservoir leakage was caused by abnormal wear on a manufacturing tool involved in the production of reservoir stoppers.
As a result, all lots of reservoirs that contain any stoppers from that tool are being recalled.
Customers are being advised to check their reservoir LOT numbers to see if they are included in the recall. This can be done by using the online tool (Medtronicdiabetes.com/checklots).
If they find they have reservoirs from affected LOT numbers, the advice is to stop using them, dispose of them safely and contact Medtronic to expedite a free replacement box. In the meantime, users are required to switch to their back-up insulin injection plan according to the direction of their healthcare professional.
Finally, Medtronic confirmed the problem has been resolved and said additional testing and inspection steps have been implemented into its manufacturing process to ensure it doesn’t happen again.
For more information on the voluntary recall, visit Medtronicdiabetes.com/support/product-updates