MiniMed™ Silhouette™ MMT-368ARecalls & 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 infusion set is a single-use subcutaneous infusion set. Reports mostly describe leaks or material deformation at the infusion site, with blood sugar swings including diabetic ketoacidosis. There are 41 reports, 1 death and 9 injuries, and no recalls name this device. Reports rose sharply to 20 in the past 12 months versus 3 previously.
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
- 52
- Deaths reported
- 1
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 05705244019478), received between Jan 19, 2022 and Sep 30, 2026 — classified as 1 death, 11 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (12 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
- Loss of or Failure to Bond12
- Premature Separation11
- Material Deformation10
- Fluid/Blood Leak9
- Adverse Event Without Identified Device or Use Problem6
- Leak/Splash4
- Material Twisted/Bent3
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Hyperglycemia8
- Hemorrhage/Blood Loss/Bleeding5
- Elevated Ketones/ Diabetic Ketoacidosis4
- Hypoglycemia2
- Coma1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
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 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 ↗MalfunctionSep 24, 2026Use of Incorrect Control/Treatment Settings
It was reported that the infusion set Pulled out by patient son due to that patient had bleeding at the site on (b)(6) 2026.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50877781 ↗MalfunctionSep 24, 2026Use of Incorrect Control/Treatment Settings
It was reported that the infusion set was accidentally pulled out by patient son on (b)(6) 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877777 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set came off from the site and patient had the bleeding at the site on (b)(6) 2026.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50864519 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced bleeding after the infusion set came off while swimming on (b)(6)2026.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50863792 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced bleeding at the insertion site after the infusion set came off, leading to leakage on (b)(6) 2026.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50863763 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced bleeding after the infusion set came off while swimming on (b)(6)2026.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50863761 ↗MalfunctionSep 20, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834060 ↗MalfunctionSep 20, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833810 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose of 380 mg/dL lasting more than four hours and treated it with a manual injection/insulin pen on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50785024 ↗InjurySep 4, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced tape not sticking event on (b)(6) 2026 due to infusion set came loose along with high blood glucose of 140 mg/dL which was treated with four units of insulin.
Patient problems: Hyperglycemia
MAUDE report 50604405 ↗MalfunctionAug 27, 2026Fluid/Blood Leak
It was reported that patient faced an event where infusion set was leaking at the site after one day of use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50475798 ↗MalfunctionAug 27, 2026Fluid/Blood Leak
It was reported that patient faced an event where infusion set was leaking at the site on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50475562 ↗MalfunctionAug 27, 2026Fluid/Blood Leak
It was reported that patient faced an event where infusion set was leaking at site on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50475559 ↗MalfunctionAug 27, 2026Fluid/Blood Leak
It was reported that patient faced an event where infusion set was leaking at site on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50475557 ↗MalfunctionAug 25, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50436597 ↗InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had high blood glucose and treated with Insulin from the pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50189778 ↗MalfunctionAug 3, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113556 ↗MalfunctionApr 23, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT PATIENT FACED INFUSION TAPE NOT STICKING ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24968167 ↗InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE ON (B)(6) 2026 WHICH WAS FURTHER TREATED WITH PUMP BOLUS.
Patient problems: Hyperglycemia
MAUDE report 24948657 ↗MalfunctionApr 8, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED TAPE NOT STICKING EVENT ON 10-MARCH-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816224 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT FACED HIGH BG AND TREATED WITH MANUAL INJECTION ON (B)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 24790372 ↗MalfunctionApr 3, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT INFUSION SET TAPE WAS NOT STICKING AND EVENTUALLY CAME OFF ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24777604 ↗MalfunctionApr 2, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT INFUSION SET TAPE WAS NOT STICKING ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769383 ↗
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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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