Medtronic Extended MMT-441AHRecalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 05705244023284), received between Jun 27, 2023 and Aug 4, 2026 — classified as 5 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (27 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 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Loss of or Failure to Bond; Premature Separation

  It was reported that the patient infusion set came off during use on (b)(6)2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125651 ↗
• MalfunctionMar 30, 2026Leak/Splash

  THIS EMDR IS BEING SUBMITTED FOR UNKNOWN NUMBER QUANTITY REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKS WITH MULTIPLE EXTENDED INFUSION SETS AT THE SITE AFTER LESS THAN 24 HOURS 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 24709578 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKS WITH MULTIPLE EXTENDED INFUSION SETS AT THE SITE AFTER LESS THAN 24 HOURS 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 24709423 ↗
• MalfunctionMar 26, 2026Leak/Splash; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFUSION SET LEAKAGE EVENT ON (B)(6) 2023. THE PATIENT OBSERVED DAMP TAPE AT THE SITE AND DETECTED THE SMELL OF INSULIN AFTER 2-3 DAYS OF USE. THE BLOOD GLUCOSE LEVEL WAS 130MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699739 ↗
• MalfunctionMar 26, 2026Leak/Splash; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. THIS EMDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER QUANTITY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFUSION SET LEAKAGE EVENT ON (B)(6) 2023. THE PATIENT OBSERVED DAMP TAPE AT THE SITE AND DETECTED THE SMELL OF INSULIN AFTER 2-3 DAYS OF USE. THE BLOOD GLUCOSE LEVEL WAS 130MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699623 ↗
• MalfunctionMar 17, 2026Loss of or Failure to Bond

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET TAPE NOT STICKING EVENT ON (B)(6) 2026. PATIENT STATED THAT IT DIDN'T HAVE THAT MUCH ADHESIVE SO IT DIDN'T STICK. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624583 ↗
• MalfunctionMar 17, 2026Loss of or Failure to Bond; Premature Separation

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THAT THE INFUSION SET SITE CAME OFF DUE TO TAPE NOT STICKING EVENT ON (B)(6) 2026. THE INFUSION SET HAD BEEN IN USE FOR FOUR DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24614607 ↗
• MalfunctionMar 13, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2026. THE LEAKAGE WAS AT THE SITE. THE INFUSION SET WAS IN USE FOR TWO DAYS. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERY SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589325 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 23287934 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 23287168 ↗
• MalfunctionSep 9, 2025Leak/Splash; Leak/Splash

  (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET LEAKAGE EVENT ON (B)(6) 2025. THE LEAKAGE WAS IN THE TUBING. THE INFUSION SET WAS IN USE FOR TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008586 ↗
• InjuryJul 16, 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 HYPERGLYCEMIA . THE BLOOD GLUCOSE LEVEL WAS 600 MG/DL AND THE PATIENT GOT TREATED WITH MANUAL INSULIN INJECTION .LENGTH OF HOSPITALIZATION WAS FOR 2 DAYS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 22516868 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 22208876 ↗
• 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 NEEDLE BREAK ON (B)(6) 2025. THE INSERTION SITE WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR SIX 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 22025292 ↗
• MalfunctionFeb 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET DETACHMENT EVENT ON (B)(6) 2024. THE SITE OF DETACHMENT WAS BLUE CLIP- CONNECTED TO RESERVOIR. THE SITE OF INSERTION WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372367 ↗
• MalfunctionNov 28, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2024. THE LEAKAGE WAS FROM THE TUBE. THE INFUSION SET WAS IN USE JUST INSERTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804123 ↗
• MalfunctionSep 26, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET LEAKS IN THE TUBING SITE NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20308690 ↗
• MalfunctionSep 19, 2024Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20253596 ↗
• MalfunctionAug 8, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED TAPE WAS NOT STICKING. THE INFUSION SET WAS IN USE FOR 3 DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19936198 ↗
• MalfunctionAug 8, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON 05-JUL-2024, IT WAS REPORTED THAT THE PATIENT FACED TAPE WAS NOT STICKING. THE INFUSION SET WAS IN USE FOR 3 DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19936192 ↗
• MalfunctionAug 7, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19935771 ↗
• MalfunctionAug 7, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19935719 ↗
• 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 PATIENT FACED AN 3 INFUSION SETS LEAKAGE EVENT AT THE SITE. THE INFUSION SET WAS IN USE FOR 4 DAYS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19916831 ↗
• 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 PATIENT FACED AN 3 INFUSION SETS LEAKAGE EVENT AT THE SITE. THE INFUSION SET WAS IN USE FOR 4 DAYS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19916826 ↗
• 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 PATIENT FACED AN 3 INFUSION SETS LEAKAGE EVENT AT THE SITE. THE INFUSION SET WAS IN USE FOR 4 DAYS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 19916814 ↗