MiniMed™ Silhouette™ MMT-383ARecalls & 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 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a MiniMed Silhouette infusion set, a single-use disposable placed under the skin to deliver insulin. Most reports describe the set coming apart, leaking fluid, or its tape not sticking so the tubing detached or insulin flow was blocked, which led to high or low blood sugar readings. There are 51 reports, with no deaths and 20 injuries. No recalls name this device. Reports rose sharply in the past 12 months, from 5 to 31.
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
- 56
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 05705244019621), received between May 28, 2021 and Sep 24, 2026 — classified as 24 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (11 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem11
- Loss of or Failure to Bond11
- Appropriate Device Problem Term/Code Not Available8
- Premature Separation7
- Detachment of Device or Device Component5
- Leak/Splash4
- Use of Incorrect Control/Treatment Settings4
- Material Twisted/Bent3
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Hyperglycemia19
- Hypoglycemia6
- Elevated Ketones/ Diabetic Ketoacidosis2
- Hemorrhage/Blood Loss/Bleeding2
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced the infusion set fell off due to the weather event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880230 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced the infusion set fell off due to the weather event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880176 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced the infusion set fell off due to the weather event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880175 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced the infusion set fell off due to the weather event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880171 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced Problem with Infusion set, which led to high blood glucose level and treated with bolus event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50836279 ↗MalfunctionSep 14, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient experienced an event where infusion set detached accidentally on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749273 ↗InjurySep 5, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50626598 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced an event of high blood glucose levels of 85 mg/dl and treated by insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50536795 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced an event of low blood glucose levels and treated by carbohydrates on (b)(6) 2026.
Patient problems: Hypoglycemia
MAUDE report 50536773 ↗InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced Low blood glucose 70mg/dl and treated with Carbs intake on (b)(6) 2026.
Patient problems: Hypoglycemia
MAUDE report 50494356 ↗MalfunctionAug 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292617 ↗MalfunctionAug 13, 2026Use of Incorrect Control/Treatment Settings
It was reported that infusion set tape not sticking due to hot whether on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230906 ↗MalfunctionAug 12, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223357 ↗MalfunctionAug 12, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220242 ↗InjuryAug 10, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50192161 ↗InjuryAug 4, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient had high blood glucose due to insulin flow blockage and treated with insulin pump event on (b)(6)2025.
Patient problems: Hyperglycemia
MAUDE report 50130297 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50120140 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE LEVEL MEASURING 67 MG/DL AND WAS TREATED BY TAKING A GLASS OF JUICE AND GLUCAGON TABLET EVENT ON (B)(6) 2026.
Patient problems: Hypoglycemia
MAUDE report 24967281 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL MEASURING 333 MG/DL AND WAS TREATED WITH CORRECTION BOLUS EVENT ON (B)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 24964439 ↗InjuryApr 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT FACED HYPERGLYCEMIA ON (B)(6) 2026. THE BLOOD GLUCOSE WAS HIGH AND THE PATIENT WAS TREATED WITH MANUAL BOLUS.
Patient problems: Hyperglycemia
MAUDE report 24919839 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT FACED HYPOGLYCEMIA EVENT ON (B)(6) 2026. THE BLOOD GLUCOSE WAS LOW AND GOT TREATED WITH CARB INTAKE.
Patient problems: Hypoglycemia
MAUDE report 24909937 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA AND WAS TREATED WITH JELLYBEANS ON (B)(6) 2026.
Patient problems: Hypoglycemia
MAUDE report 24867983 ↗InjuryApr 9, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2026. BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF THE EVENT AND PATIENT TOOK INSULIN PEN TO RESOLVE THE ISSUE.
Patient problems: Hyperglycemia
MAUDE report 24827312 ↗InjuryApr 9, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2026. BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF THE EVENT AND PATIENT TOOK INSULIN PEN TO RESOLVE THE ISSUE.
Patient problems: Hyperglycemia
MAUDE report 24826970 ↗InjuryApr 9, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM EVENT ON 26-FEB-2026. BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF THE EVENT AND PATIENT TOOK INSULIN PEN TO RESOLVE THE ISSUE.
Patient problems: Hyperglycemia
MAUDE report 24826956 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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