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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside…"
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.
Related recalls
Same manufacturer · Medtronic MiniMed
See all →- HighGuardian Glucose Monitoring App May Automatically Log Out and Block Data Upload
FDA (Devices) · 2023-01-11
- HighInsulin Pump Cybersecurity Vulnerability Allows Unauthorized Remote Access
FDA (Devices) · 2022-11-16
- HighMedtronic MiniMed Insulin Pumps Recalled for Cybersecurity Vulnerability
FDA (Devices) · 2022-11-16
- HighMiniMed 780G Insulin Pump battery cap deterioration may cause power loss
FDA (Devices) · 2022-07-20
- HighMiniMed 620G insulin pump battery cap deterioration may cause power loss
FDA (Devices) · 2022-07-20
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighMedtronic MiniMed Paradigm Insulin Pumps Recalled for Programming Error
FDA (Devices) · 2014-09-03
- HighMedtronic Recalls Paradigm Insulin Pumps Due to Cap Detachment Risk
FDA (Devices) · 2013-04-17
- HighMedtronic Paradigm insulin pump recall for abnormal delivery during flight
FDA (Devices) · 2025-03-12
- HighParadigm insulin pump delivery varies with pump height changes
FDA (Devices) · 2026-04-08
- HighMedtronic MiniMed Paradigm Reservoirs Recalled for Potential Leaking Risk
FDA (Devices) · 2013-08-28
- SevereMedtronic MiniMed Infusion Sets Recalled Due to Tubing Detachment Risk
FDA (Devices) · 2014-12-17