MiniMed™ Silhouette™ MMT-377ARecalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 05705244019508), received between Aug 24, 2021 and Sep 14, 2026 — classified as 16 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (39 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 69 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Use of Incorrect Control/Treatment Settings

  It was reported that the pump dropped on the floor and have cosmetic damage leading to high blood glucose treated with manual insulin injection, on (b)(6) 2026.

  Patient problems: Hyperglycemia

  MAUDE report 50749310 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced low blood glucose on (b)(6) 2026 which was treated with food intake.

  Patient problems: Hypoglycemia

  MAUDE report 50444904 ↗
• MalfunctionAug 8, 2026Partial Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50186891 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a hyperglycemic episode on (b)(6) 2026, which successfully managed with self-administered insulin via pump which resulting in stable blood glucose levels with no reported complications.

  Patient problems: Hyperglycemia

  MAUDE report 50035950 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  To date, additional patient or event details were received which have been added in H11 (Addl Mfg narrative).

  Patient problems: Hyperglycemia

  MAUDE report 50022995 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED HYPOGLYCEMIA EVENT ON (B)(6) 2026 AND LOW BLOOD GLUCOSE AND TREATED WITH EATING ORANGE AND NUTS.

  Patient problems: Hypoglycemia

  MAUDE report 25500653 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA AND WAS TREATED WITH GLUCAGON SHOTS ON (B)(6) 2026, HENCE NO MALFUNCTION RELATED TO THE INFUSION SET.

  Patient problems: Hypoglycemia

  MAUDE report 24977354 ↗
• InjuryApr 23, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCK ON (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT GOT TREATED WITH BOLUS

  Patient problems: Hyperglycemia

  MAUDE report 24965543 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2026 AND WAS TREATED WITH DELIVERED BOLUS USING THE PUMP AND MANUAL INJECTION.

  Patient problems: Hyperglycemia

  MAUDE report 24965058 ↗
• InjuryApr 23, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET CANNULA KINKED ON (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT GOT TREATED WITH BOLUS.

  Patient problems: Hyperglycemia

  MAUDE report 24963677 ↗
• InjuryApr 5, 2026Adverse Event Without Identified Device or Use Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURED IN UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED HIGH BLOOD GLUCOSE LEVEL, DIABETIC KETOACIDOSIS EVENT AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2026. THE PATIENT WAS TREATED VIA MULTIPLE DAILY INJECTIONS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 24786809 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET TUBING DETACHED AT THE QUICK RELEASE ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR SIX HOURS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711568 ↗
• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2023. THE LEAKAGE WAS AT THE SITE. THE INFUSION SET WAS IN USE FOR ONE DAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701450 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL EVENT ON (B)(6) 2026. THE PATIENT'S BLOOD GLUCOSE WAS 288MG/DL AND WAS TREATED WITH MANUAL BOLUS VIA INSULIN PUMP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 24679022 ↗
• MalfunctionJan 6, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON (B)(6) 2025. THE INSERTION SITE WAS THE LEFT ABDOMEN. THE TUBING GOT DETACHED FROM CONNECTOR. INFUSION SET WAS USED FOR ATLEAST TWO DAYS. BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 23971364 ↗
• InjuryDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET DETACHMENT EVENT ON (B)(6) 2025 WHILE WALKING. THE INSERTION SITE WAS RIGHT ABDOMEN. THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846857 ↗
• MalfunctionMay 27, 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 22085470 ↗
• MalfunctionMay 19, 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. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042523 ↗
• MalfunctionMay 15, 2025Material Perforation; Material Perforation

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED FIVE INFUSION SET CANNULA SEEMS TO BREAK ON (B)(6) 2025. THE INSERTION SITE WAS RIGHT THIGH. THE INFUSION SET WAS IN USE FOR THREE DAYS THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024066 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 ON (B)(6) 2025 DUE TO HYPOGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 37MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH GLOCUSE GUMMIES. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 21982617 ↗
• MalfunctionMay 5, 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. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958296 ↗
• MalfunctionApr 2, 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. THE BLOCKAGE WAS IN THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750046 ↗
• InjurySep 19, 2024Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET CANNULA CRIMPED EVENT. DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20262018 ↗
• MalfunctionAug 28, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET BLOCKED ALARM EVENT ON (B)(6) 2024 DUE TO RESERVOIR ISSUES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084537 ↗
• MalfunctionAug 26, 2024Infusion 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 BLOCK ALARM EVENT ON 28-JUL-2024. THE BLOCKAGE WAS LOCATED IN THE TUBING CONNECTOR TO RESERVOIR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072799 ↗