MiniMed SilhouetteRecalls & reported problems across all models
Unomedical A/S · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 909
- Deaths reported
- 6
- Injuries reported
- 276
- Recalls
- 0
We found 7 models of MiniMed Silhouette by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 909 adverse event reports in the FDA's MAUDE database, received between Jun 9, 2020 and Sep 30, 2026 — classified as 6 deaths, 276 injuries, 627 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (190 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MiniMed Silhouette problems
Device problems
- Loss of or Failure to Bond190
- Adverse Event Without Identified Device or Use Problem185
- Premature Separation180
- Detachment of Device or Device Component119
- Leak/Splash112
- Infusion or Flow Problem52
- Fluid/Blood Leak51
- Material Twisted/Bent33
Patient problems
- No Clinical Signs, Symptoms or Conditions571
- Hyperglycemia199
- Hypoglycemia57
- Elevated Ketones/ Diabetic Ketoacidosis48
- Hemorrhage/Blood Loss/Bleeding20
- Unspecified Infection8
- Shaking/Tremors6
- Skin Infection4
MiniMed Silhouette models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MiniMed™ Silhouette™ MMT-381ASet, Administration, Intravascular2 deaths496 reports
- MiniMed™ Silhouette™ MMT-378ASet, Administration, Intravascular3 deaths131 reports
- MiniMed™ Silhouette™ MMT-382ASet, Administration, Intravascular93 reports
- MiniMed™ Silhouette™ MMT-377ASet, Administration, Intravascular69 reports
- MiniMed™ Silhouette™ MMT-383ASet, Administration, Intravascular56 reports
- MiniMed™ Silhouette™ MMT-368ASet, Administration, Intravascular1 death52 reports
- MiniMed™ Silhouette™ MMT-384ASet, Administration, Intravascular12 reports
Recent MiniMed Silhouette adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that patient experienced high BG around 400 mg/dL, indicating possible infusion set-related therapy interruption and no treatment was documented due to reservoir leak at the O-rings during normal use with fluid/insulin visible in the pump compartment on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50942791 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an elevated blood glucose and was treated with insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50927682 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914344 ↗InjurySep 28, 2026Fluid/Blood Leak; Detachment of Device or Device Component
It was reported that patient used infusion set for 3 days and infusion set tubing came apart and had high blood glucose level treated with pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50913973 ↗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 ↗MalfunctionSep 27, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910141 ↗InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50909985 ↗MalfunctionSep 27, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909930 ↗MalfunctionSep 27, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909913 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909586 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908184 ↗
Other Unomedical A/S products
- Autosoft XC11 models · 31,720 reports
- MiniMed Infusion Sets58 models · 30,240 reports
- Medtronic Extended27 models · 22,785 reports
- Autosoft9021 models · 20,579 reports · 1 recall
- Minimed Quick-set18 models · 16,559 reports
- MiniMed Mio Advance12 models · 11,094 reports
- TruSteel5 models · 4,387 reports
- Autosoft307 models · 3,945 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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