MiniMed™ Sure T™ MMT-874ARecalls & 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 Sure T (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This MiniMed Sure-T infusion set is a single-use tube set for subcutaneous insulin infusion. Its 98 adverse event reports include no deaths, 34 injuries and 64 malfunctions. The reports mostly describe the set separating early or failing to stick to the skin, and some patients report high blood sugar. Reports in the last 12 months number 43, up from 26 in the year before. No recalls name this device.
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
- 133
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 05705244019355), received between Nov 17, 2020 and Sep 30, 2026 — classified as 48 injuries, 85 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (44 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 Bond44
- Adverse Event Without Identified Device or Use Problem38
- Premature Separation29
- Detachment of Device or Device Component16
- Infusion or Flow Problem11
- Appropriate Device Problem Term/Code Not Available4
- Complete Blockage4
- Fluid/Blood Leak4
Patient problems
- No Clinical Signs, Symptoms or Conditions79
- Hyperglycemia31
- Hypoglycemia14
- Elevated Ketones/ Diabetic Ketoacidosis9
- Diaphoresis1
- Unspecified Infection1
- Urinary Frequency / Polyuria1
Recent adverse event reports
The 25 most recent of 133 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951641 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950459 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to sweating working caused tape to fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942816 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set sweating working caused tape to fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942813 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to sweating working caused tape to fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942642 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to swimming on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942639 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set due to sweating working caused tape to fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942610 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to sweating working caused tape to fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942608 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to sweating working caused tape to fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942607 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hyperglycemia event on (b)(6)2026 which was treated with pen injection.
Patient problems: Hyperglycemia
MAUDE report 50942064 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the Patient faced an event where Tape Not Sticking and fell off due to sweating & working on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941787 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931098 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931095 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929739 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929738 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927691 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape fell off due to sweat on (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927684 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced low blood glucose event on (b)(6) 2026 which was addressed by intake of apple juice along with dextrose energy clementines.
Patient problems: Hypoglycemia
MAUDE report 50911920 ↗InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50910082 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Diaphoresis; Hyperglycemia; Urinary Frequency / Polyuria
MAUDE report 50907195 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50907193 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 50906851 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that the patient faced an event where leakage at site on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883268 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that the patient faced an event where leakage at site on (b)(6)2026. The set was used for one day.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883264 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that infusion set leaked at the insertion site after one day of use with no reported stress or pull on the tubing (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877520 ↗
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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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