Medtronic Extended MMT-442AHRecalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 05705244023314), received between Sep 4, 2023 and Sep 15, 2026 — classified as 5 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (41 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 75 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced low blood glucose level and was treated by eating and drinking the coke event on (b)(6)2026.

  Patient problems: Hypoglycemia

  MAUDE report 50766942 ↗
• InjurySep 13, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: Hyperglycemia

  MAUDE report 50747185 ↗
• MalfunctionAug 10, 2026Fluid/Blood Leak

  It was reported that patient faced infusion set was leaking at insertion site event on (b)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189836 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection; Hyperglycemia

  MAUDE report 50161615 ↗
• MalfunctionAug 3, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50116916 ↗
• InjuryJun 7, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Hyperglycemia

  MAUDE report 25422326 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET LEAKAGE ON (B)(6) 2024. THE PATIENT REPORTED FOUR INFUSION SETS FAILED AT THE SITE AFTER APPROXIMATELY FOUR DAYS OF USE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713609 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET LEAKAGE ON (B)(6) 2024. THE PATIENT REPORTED FOUR INFUSION SETS FAILED AT THE SITE AFTER APPROXIMATELY FOUR DAYS OF USE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713266 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET LEAKAGE ON (B)(6) 2024. THE PATIENT REPORTED FOUR INFUSION SETS FAILED AT THE SITE AFTER APPROXIMATELY FOUR DAYS OF USE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713131 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET LEAKAGE ON (B)(6) 2024. THE PATIENT REPORTED FOUR INFUSION SETS FAILED AT THE SITE AFTER APPROXIMATELY FOUR DAYS OF USE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713065 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE AT SITE EVENT ON (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712272 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EXTENDED INFUSION SET LEAK AT THE SITE AFTER 2 DAYS OF USE, WITH NO STRESS ON TUBING ON (B)(6) 2023. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709511 ↗
• 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 INFUSION SET ON (B)(6) 2023 AS THE INFUSION SET TUBING WAS DETACHED FROM THE SITE CONNECTOR AND THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT HAD HIGH BLOOD GLUCOSE AND THE CURRENT BLOOD GLUCOSE LEVEL DOCUMENTED WAS 180 MG/DL. THE EVENT OCCURRED WHILE SLEEPING AND THE SITE OF INSERTION WAS RIGHT AND LEFT OF THE LOWER SIDE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699095 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURED IN CANADA. THE PATIENT REQUIRED EMERGENCY MEDICAL ATTENTION AND WAS TAKEN TO THE ER ON (B)(6) 2025. THE HOSPITALIZATION LASTED FOR A BRIEF PERIOD OF JUST 5 HOURS. UPON ADMISSION TO THE HOSPITAL, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS RECORDED AT 25 MMOL/L. THE PRIMARY SYMPTOM REPORTED BY THE PATIENT AT THE TIME OF HOSPITALIZATION WAS VOMITING. DURING THE HOSPITAL STAY, INSULIN WAS ADMINISTERED TO THE PATIENT VIA AN INSULIN PUMP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Vomiting

  MAUDE report 22086275 ↗
• MalfunctionNov 27, 2024Infusion 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 20795726 ↗
• MalfunctionOct 9, 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 OCCLUSION AT THE TUBING EVENT ON (B)(6) 2024. THE BLOOD GLUCOSE LEVEL WAS 307 MG/DL AT THE TIME OF EVENT, THEREFORE THE PATIENT WAS TREATED WITH BOLUS FROM PUMP. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 20407834 ↗
• MalfunctionSep 13, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET HAD LEAKAGE AT QUICK RELEASE SITE. THE INFUSION SET WAS IN USE FOR 2 TO 3 DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20209307 ↗
• MalfunctionSep 13, 2024Leak/Splash; Leak/Splash

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20209305 ↗
• MalfunctionSep 11, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKING AT THETUBING SITE EVENT ON (B)(6) 2024. THE BLOOD GLUCOSE LEVEL WAS FOUND TO BE HIGH. THE PATIENT TOOK BOLUS WITH PUMP. NO FURTHER INFORMATION AVAILABLE .

  Patient problems: Hyperglycemia

  MAUDE report 20188378 ↗
• MalfunctionAug 8, 2024Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET CANNULA WAS CRIMPED ON (B)(6) 2024. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19946222 ↗
• MalfunctionAug 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT WHERE INFUSION SET PULLED OUT ON 06-JUL-2024. THE BLOOD GLUCOSE LEVEL WAS 22.2 MMOL/L AT THE TIME OF EVENT THEREFORE, THE PATIENT WAS TREATED WITH BOLUS CORRECTION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19921318 ↗
• MalfunctionAug 3, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET WAS LEAKING AT THE SITE. THE INFUSION SET WAS IN USE FOR THREE DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19901528 ↗
• MalfunctionAug 3, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER 1931135. EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET WAS LEAKING AT THE SITE. THE INFUSION SET WAS IN USE FOR THREE DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19901521 ↗
• MalfunctionAug 3, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 27-JUN-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET WAS LEAKING AT THE SITE. THE INFUSION SET WAS IN USE FOR THREE DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19901518 ↗
• MalfunctionAug 3, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. ON (B)(6)2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET WAS LEAKING AT THE SITE. THE INFUSION SET WAS IN USE FOR THREE DAYS. NO FURTHER INFORMATION AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19901516 ↗