MiniMed™ Silhouette™ MMT-378ARecalls & reported problems
Unomedical A/S · Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2
All models of MiniMed Infusion Sets (58) · MiniMed Silhouette (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This MiniMed Silhouette MMT-378A infusion set is a single-use device for subcutaneous insulin delivery. Reports mostly describe sets becoming detached or separated, cannulas bending or twisting, and infusion or flow problems; patients report high blood sugar, ketones, low blood sugar and bleeding. There are 100 reports, 3 deaths and 36 injuries. No recalls name this device. Reports rose from 24 to 45 over the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 131
- Deaths reported
- 3
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 05705244019539), received between Jan 7, 2021 and Sep 30, 2026 — classified as 3 deaths, 58 injuries, 70 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem40
- Detachment of Device or Device Component17
- Loss of or Failure to Bond17
- Premature Separation14
- Infusion or Flow Problem12
- Use of Incorrect Control/Treatment Settings12
- Material Twisted/Bent10
- Device Handling Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- Hyperglycemia31
- Hypoglycemia20
- Elevated Ketones/ Diabetic Ketoacidosis13
- Shaking/Tremors5
- Coma1
- Confusion/ Disorientation1
- Cramp(s) /Muscle Spasm(s)1
Recent adverse event reports
The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Deformation Due to Compressive Stress; Material Twisted/Bent
It was reported that patient experienced high blood glucose level of 784 MG/DL on (b)(6)2026 and hospitalized on (b)(6) 2026 for less than twenty four hours due to infusion set tubing leak with kink and under-delivery and associated with symptoms was Feeling sick, unwell Flu like Headache Tired and Increased thirst.
Patient problems: Fatigue; Headache; Hyperglycemia; Muscle Weakness/Atrophy; Polydipsia
MAUDE report 50942792 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced low blood glucose on (b)(6) 2026 which was treated by carbs intake.
Patient problems: Hypoglycemia
MAUDE report 50913835 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6)2026 where the infusion set tape was not sticking due to due to perspiration because of weather conditions.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913071 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6)2026 where the infusion set tape was not sticking due to due to perspiration because of weather conditions.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913063 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced infusion set tape not sticking due to weather conditions and perspiration event on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912049 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hyperglycemia event on (b)(6) 2026, which was treated via insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50880856 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hyperglycemia event on (b)(6) 2026, which was treated via insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50880850 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50880845 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hyperglycemia event on (b)(6) 2026, which was treated via insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50880821 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hyperglycemia event on (b)(6) 2026, which was treated via insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50880816 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hyperglycemia event on (b)(6) 2026, which was treated via insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50880814 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hyperglycemia event on (b)(6) 2026, which was treated via insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50880809 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hyperglycemia event on (b)(6) 2026, which was treated via insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50880804 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an event where a hypoglycemia treated via orange juice and peanut butter crackers on (b)(6) 2026.
Patient problems: Hypoglycemia
MAUDE report 50863940 ↗InjurySep 18, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50823001 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced hyperglycemia (213 MG/DL) event on (b)(6) 2026 and was treated with Correction through pump.
Patient problems: Hyperglycemia
MAUDE report 50770337 ↗InjurySep 8, 2026Device Handling Problem
It was reported that patient experienced low blood glucose after using expired infusion set along with symptoms Shaky and cloudy mind which was addressed by carbohydrates on (b)(6) 2026.
Patient problems: Hypoglycemia; Shaking/Tremors
MAUDE report 50667872 ↗InjurySep 8, 2026Device Handling Problem
It was reported that patient experienced low blood glucose after using expired infusion set along with symptoms Shaky and cloudy mind which was addressed by carbohydrates on (b)(6) 2026.
Patient problems: Hypoglycemia; Shaking/Tremors
MAUDE report 50667844 ↗InjurySep 8, 2026Device Handling Problem
It was reported that patient experienced low blood glucose after using expired infusion set along with symptoms Shaky and cloudy mind which was addressed by carbohydrates on (b)(6) 2026.
Patient problems: Hypoglycemia; Shaking/Tremors
MAUDE report 50667829 ↗InjurySep 8, 2026Device Handling Problem
It was reported that patient experienced low blood glucose after using expired infusion set along with symptoms Shaky and cloudy mind which was addressed by carbohydrates on (b)(6) 2026.
Patient problems: Hypoglycemia; Shaking/Tremors
MAUDE report 50667828 ↗InjurySep 8, 2026Device Handling Problem
It was reported that patient experienced low blood glucose after using expired infusion set along with symptoms Shaky and cloudy mind which was addressed by carbohydrates on (b)(6) 2026.
Patient problems: Hypoglycemia; Shaking/Tremors
MAUDE report 50667827 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50644260 ↗InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an event of high blood glucose of 216mg/dl that was treated via pump on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50607438 ↗MalfunctionSep 1, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50536497 ↗MalfunctionAug 31, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50518054 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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