MiniMed™ Sure T™ MMT-886ARecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05705244019447), received between Sep 24, 2020 and Sep 30, 2026 — classified as 6 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  It was reported by the patient that tape was not sticking on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948216 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  It was reported that patient face issue with tape not sticking on (b)(6)2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943227 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  It was reported that patient face issue with tape not sticking on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943095 ↗
• MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827239 ↗
• MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50822392 ↗
• MalfunctionSep 16, 2026Loss of or Failure to Bond; Premature Separation

  It was reported that the patient experienced an event where an Infusion set tape not sticking due to perspiration on 15 Aug 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50783449 ↗
• InjurySep 13, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hypoglycemia

  MAUDE report 50747796 ↗
• MalfunctionSep 1, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50537923 ↗
• MalfunctionSep 1, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50536343 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced high blood glucose event (300 mg/dL) on (b)(6) 2026 and it was addressed by manual bolus via pump.

  Patient problems: Hyperglycemia

  MAUDE report 50017348 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO HYPOGLYCEMIA ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 24659045 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET CANNULA NEEDLE BREAK EVENT ON (B)(6) 2025. THE EVENT OCCURRED DURING INSERTION. THE INSERTION SITE WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR LESS THAN ONE DAY. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568105 ↗
• MalfunctionNov 13, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE IS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23540439 ↗
• InjuryNov 11, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025 DUE TO WHICH PATIENT HAD ISSUE WITH SITE AND GOT AN ABSCESS AND HAD TO DRAIN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 23519477 ↗
• MalfunctionSep 12, 2025Infusion or Flow Problem; Infusion or Flow Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23035338 ↗
• MalfunctionJun 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED KINGDOM. IT WAS REPORTED THAT PATIENT FACED INFUSION SET DETACHMENT EVENT ON 27 MAY-2025. THE SITE OF DETACHMENT WAS CONNECTOR. THE INFUSION SET WAS IN USE FOR 1 DAY. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22173207 ↗
• MalfunctionJun 4, 2025Crack; Crack

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN HUNGARY. IT WAS REPORTED THAT PATIENT FACED A CRIMPED INFUSION SET TUBING EVENT ON (B)(6) 2025 AT SET CONNECTOR. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH SUBCUTANEOUS INSULIN INJECTION AFTER INFUSION SET CHANGE. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 22139759 ↗
• MalfunctionMar 19, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKAGE EVENT ON (B)(6) 2025 DUE TO BLOCKAGE IN TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21640651 ↗
• MalfunctionDec 5, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN POLAND. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2024. THE BLOCKAGE WAS IN THE TUBING. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852081 ↗
• MalfunctionSep 28, 2024Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET INSULIN FLOW BLOCKED DUE TO BENT NEEDLE ON (B)(6) 2024.PATIENT ALSO EXPERIENCED BLEEDING AFTER REMOVING THE NEEDLE FROM THE BODY. THE INFUSION SET HAS BEEN USED FOR 1-2 DAYS. THE INSERTION SITE WAS ABDOMEN. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20328801 ↗
• MalfunctionSep 24, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT, THE PATIENT EXPERIENCED INSULIN FLOW BLOCK ALARM EVENT ON (B)(6) 2024.THE BLOCKAGE WAS LOCATED AT THE TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20290450 ↗
• MalfunctionAug 31, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES, IT WAS REPORTED THAT ON (B)(6) 2024 PATIENT REPORTED LEAKING FOR INFUSION SET AND RESERVOIR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113940 ↗
• MalfunctionAug 8, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE POLAND. IT WAS REPORTED THAT PATIENT FACED INFUSION SET BLOCKAGE IN TUBING EVENT ON 08-JUL-2024. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19936114 ↗
• MalfunctionJul 8, 2024Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRIA. ON 07-JUN-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKED FROM THE ADHESIVE. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689161 ↗
• MalfunctionJun 26, 2024Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRIA. IT WAS REPORTED THAT PATIENT EXPERIENCED THAT THE INFUSION SET WAS LEAKED AT INSERTION SITE. THE INFUSION SET WAS USED FOR ONE DAY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613718 ↗