Sure-T ParadigmRecalls & reported problems across all models

We found 8 models of Sure-T Paradigm by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 238 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2018 and Sep 18, 2026 — classified as 1 death, 30 injuries, 207 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (194 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

Most reported Sure-T Paradigm problems

Sure-T Paradigm models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Sure-T® Paradigm® MMT-864

  Set, Administration, Intravascular
  1 death102 reports
• Sure-T® Paradigm® MMT-866

  Set, Administration, Intravascular
  68 reports
• Sure-T® Paradigm® MMT-876

  Set, Administration, Intravascular
  22 reports
• Sure-T® Paradigm® MMT-862

  Set, Administration, Intravascular
  18 reports
• Sure-T® Paradigm® MMT-886

  Set, Administration, Intravascular
  13 reports
• Sure-T® Paradigm® MMT-874

  Set, Administration, Intravascular
  10 reports
• Sure-T® Paradigm® MMT-864T

  Set, Administration, Intravascular
  4 reports
• Sure-T® Paradigm® MMT-884

  Set, Administration, Intravascular
  1 report

Recent Sure-T Paradigm adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Handling Problem

  Patient problems: Hypoglycemia

  MAUDE report 50822402 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced high blood glucose of 400mg/dl and was treated with bolus delivered via the pump on (b)(6) 2026.

  Patient problems: Hyperglycemia

  MAUDE report 50517668 ↗
• MalfunctionAug 26, 2026Fluid/Blood Leak

  It was reported that patient faced insulin did not exit the tubing event on (b)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50447910 ↗
• InjuryAug 17, 2026Fluid/Blood Leak

  It was reported that patient experienced infusion set was leaking at the tubing on (b)(6) 2026 which led to high blood glucose and it was addressed by correction bolus.

  Patient problems: Hyperglycemia

  MAUDE report 50268948 ↗
• MalfunctionAug 6, 2026Premature Separation

  Patient problems: Skin Infection

  MAUDE report 50156969 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced high blood glucose and it was corrected by insulin pen event on (b)(6)2026.

  Patient problems: Hyperglycemia

  MAUDE report 50141605 ↗
• MalfunctionAug 3, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50108754 ↗
• InjuryJul 7, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT FACED HIGH BLOOD GLUCOSE TREATED WITH INJECTION ON (B)(6) 2026.

  Patient problems: Hyperglycemia

  MAUDE report 25734527 ↗
• DeathJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED AND DIED ON (B)(6) 2020 AND THE CAUSE OF DEATH IS HEART ATTACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25500641 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED HYPERGLYCEMIA EVENT ON (B)(6) 2026 AND TREATED WITH INSULIN USING PUMP.

  Patient problems: Hyperglycemia

  MAUDE report 24964331 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AFTER FAINTING DUE TO HYPOGLYCEMIA, AND THE LOW BLOOD GLUCOSE EVENT WAS TREATED WITH INTRAVENOUS INSULIN AND PUMP THERAPY.

  Patient problems: Hypoglycemia

  MAUDE report 24964173 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH THE INFUSION SET ON (B)(6) 2023 AS THE NEW INFUSION SET TUBING CONNECTOR WAS DAMAGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24951230 ↗
• InjuryMar 26, 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. THE PATIENTS BLOOD GLUCOSE LEVEL WAS 20 MG/DL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 24701182 ↗
• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFUSION SET LEAKAGE EVENT ON (B)(6) 2023. THE PATIENT REPORTED THAT THE INFUSION SET WAS LEAKING AT THE INSERTION SITE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699640 ↗
• MalfunctionMar 26, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH THE INFUSION SET ON (B)(6) 2023 AS THE NEW INFUSION SET TUBING CONNECTOR WAS DAMAGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699084 ↗

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