Medtronic MiniMed Paradigm Insulin Infusion Sets Recalled for Malfunction Risk
Medtronic MiniMed is recalling Paradigm insulin infusion sets because they may malfunction and deliver incorrect insulin volumes if exposed to fluids.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (insulin delivery device) where injury has not yet been reported, fitting the High severity criteria for potential malfunction without confirmed adverse events.
Plain-English summary
Medtronic MiniMed is recalling approximately 11,000,000 units of Paradigm insulin infusion sets. These products are intended for use with Paradigm insulin infusion pumps and were distributed worldwide, including nationwide in the United States.
The recall is being conducted due to a potential safety issue where the infusion sets may malfunction if insulin or other fluids come into contact with the inside of the device. Under certain conditions, this malfunction can result in the delivery of an incorrect volume of insulin.
The affected models include 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, and MMT-975. Consumers should check their infusion set model numbers and contact Medtronic MiniMed for further instructions.
The recalled product
- Product
- Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
- Manufacturer
- Medtronic MiniMed
- Affected units
- 11,000,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- This field correction involves models: 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
Distribution
Distributed nationwide across the United States.
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