On July 7, 2013, the US Food and Drug Administration (FDA) reclassified Medtronic’s voluntary June recall of Medtronic Minimed Paradigm infusion sets as a class I recall (the most serious type of recall). The recall was initiated because the infusion sets have the potential to cause over- or under-delivery of insulin, which could result in low or high blood glucose levels.
If insulin or other fluids come in contact with the inside of the connector on Medtronic Paradigm infusion sets, the liquid can temporarily block the vents in the connector that allow the pump to properly prime. If the vents are blocked, this can lead to too much or too little insulin being delivered, potentially resulting in hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose). According to Medtronic, ” Exposure of the inside of the infusion set connector to fluid is most likely to occur if insulin is spilled on the top of the insulin reservoir when the reservoir is removed from the transfer guard after filling the reservoir from a vial of insulin.”
The following thirty-seven models of the infusion set are affected: MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975.
If customers notice anything unusual during the infusion set prime process, such as the insulin continuing to drip from the tip of the infusion set cannula once the priming has been completed (which may indicate that the connector vents are not working properly), they are advised not to use the set and to immediately contact Medtronic’s 24-hour helpline at (888) 204-7616 for assistance.
Medtronic began the process of notifying the FDA, customers, health-care providers, distributors, and partners of the recall on June 7, 2013.
No product returns are required as a result of this recall, and Medtronic notes that “when the reservoir fill process and priming procedures are followed according to the instructions, the Paradigm reservoirs and infusion sets in the Paradigm pumps should work as they are supposed to.” Videos and reference guides demonstrating the reservoir fill process for certain Paradigm pumps are available here, and steps for preventing fluid from blocking the connector vents can be found here.
Health-care professionals and users of the infusion sets are encouraged to report side effects and adverse events related to its use to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, either online, by faxing a completed reporting form to (800) FDA-0178 (332-0178), or by mailing a completed form to the address printed on the form.