Minimed™ Mio™ MMT-941A600Recalls & reported problems
Unomedical A/S · Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2
All models of MiniMed Infusion Sets (58) · Minimed Mio (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a MiniMed Mio MMT-941A600 infusion set, a single-use set placed under the skin to deliver insulin. The 30 reports mostly describe the set leaking at the insertion site or where it clips to the pump, coming loose early, or adhesive not holding (some attributed to sleeping or showering). All 30 describe malfunctions with no injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05705244020306), received between May 18, 2024 and Apr 17, 2026 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (20 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash20
- Premature Separation6
- Loss of or Failure to Bond3
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Premature Separation
IT WAS REPORTED THAT PATIENT EXPERIENCED INFUSION SET DETACHMENT ON (B)(6) 2026, ATTRIBUTED TO SLEEPING AND SHOWERING AFFECTING ADHESIVE INTEGRITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912654 ↗MalfunctionApr 17, 2026Premature Separation
IT WAS REPORTED THAT PATIENT EXPERIENCED INFUSION SET DETACHMENT ON (B)(6) 2026, ATTRIBUTED TO SLEEPING AND SHOWERING AFFECTING ADHESIVE INTEGRITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912544 ↗MalfunctionApr 17, 2026Premature Separation
IT WAS REPORTED THAT PATIENT EXPERIENCED INFUSION SET DETACHMENT ON (B)(6) 2026, ATTRIBUTED TO SLEEPING AND SHOWERING AFFECTING ADHESIVE INTEGRITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912440 ↗MalfunctionApr 17, 2026Premature Separation
IT WAS REPORTED THAT PATIENT EXPERIENCED INFUSION SET DETACHMENT ON (B)(6) 2026, ATTRIBUTED TO SLEEPING AND SHOWERING AFFECTING ADHESIVE INTEGRITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912437 ↗MalfunctionApr 17, 2026Premature Separation
IT WAS REPORTED THAT PATIENT EXPERIENCED INFUSION SET DETACHMENT ON (B)(6) 2026, ATTRIBUTED TO SLEEPING AND SHOWERING AFFECTING ADHESIVE INTEGRITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912348 ↗MalfunctionApr 17, 2026Premature Separation
IT WAS REPORTED THAT PATIENT EXPERIENCED INFUSION SET DETACHMENT ON (B)(6) 2026, ATTRIBUTED TO SLEEPING AND SHOWERING AFFECTING ADHESIVE INTEGRITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912148 ↗MalfunctionMar 26, 2026Leak/Splash
REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON 09-NOV-2023. THE LEAKAGE WAS AT THE SITE. THE INFUSION SET WAS IN USE FOR ONE AND A HALF 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 24701467 ↗MalfunctionJun 13, 2025Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE FROM 6 OUT OF 10 INFUSION SETS ON (B)(6) 2024. THE LEAKAGE WAS FROM THE BOTTOM THAT CLIPS TO THE PUMP. THE INFUSION SET WAS IN USE FOR NOT A COMPLETE DAY. NO FURTHER INFORMATION IS AVALIABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22200511 ↗MalfunctionJun 13, 2025Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE FROM 6 OUT OF 10 INFUSION SETS ON (B)(6) 2024. THE LEAKAGE WAS FROM THE BOTTOM THAT CLIPS TO THE PUMP. THE INFUSION SET WAS IN USE FOR NOT A COMPLETE DAY NO FURTHER INFORMATION IS AVALIABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22200509 ↗MalfunctionJun 13, 2025Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE FROM 6 OUT OF 10 INFUSION SETS ON (B)(6) 2024. THE LEAKAGE WAS FROM THE BOTTOM THAT CLIPS TO THE PUMP. THE INFUSION SET WAS IN USE FOR NOT A COMPLETE DAY. NO FURTHER INFORMATION IS AVALIABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22200506 ↗MalfunctionJun 13, 2025Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE FROM 6 OUT OF 10 INFUSION SETS ON (B)(6) 2024. THE LEAKAGE WAS FROM THE BOTTOM THAT CLIPS TO THE PUMP. THE INFUSION SET WAS IN USE FOR NOT A COMPLETE DAY. NO FURTHER INFORMATION IS AVALIABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22200505 ↗MalfunctionJun 13, 2025Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE FROM 6 OUT OF 10 INFUSION SETS ON (B)(6) 2024. THE LEAKAGE WAS FROM THE BOTTOM THAT CLIPS TO THE PUMP. THE INFUSION SET WAS IN USE FOR NOT A COMPLETE DAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22200503 ↗MalfunctionJun 13, 2025Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE FROM 6 OUT OF 10 INFUSION SETS ON (B)(6) 2024. THE LEAKAGE WAS FROM THE BOTTOM THAT CLIPS TO THE PUMP. THE INFUSION SET WAS IN USE FOR NOT A COMPLETE DAY. NO FURTHER INFORMATION IS AVALIABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22200502 ↗MalfunctionOct 7, 2024Infusion or Flow Problem; Infusion or Flow Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA, IT WAS REPORTED THAT ON (B)(6) 2024 OCCLUSION ALARM OCCURRED AND INSULIN SLOWLY EXIT THROUGH TUBING AFTER TROUBLESHOOTING. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20381395 ↗MalfunctionJun 21, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE CANADA. IT WAS REPORTED ISSUES WITH 3 INFUSION SETS WHERE 2 INFUSION SETS FELL OFF AFTER 2 HOURS AND THE THIRD ONE FELL OFF AFTER 24 HOUR. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19590414 ↗MalfunctionJun 21, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE CANADA. IT WAS REPORTED ISSUES WITH 3 INFUSION SETS WHERE 2 INFUSION SETS FELL OFF AFTER 2 HOURS AND THE THIRD ONE FELL OFF AFTER 24 HOUR. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19590410 ↗MalfunctionJun 21, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE CANADA. IT WAS REPORTED ISSUES WITH 3 INFUSION SETS WHERE 2 INFUSION SETS FELL OFF AFTER 2 HOURS AND THE THIRD ONE FELL OFF AFTER 24 HOUR. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19590405 ↗MalfunctionMay 27, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE CANADA ON 26-APR-2024, IT WAS REPORTED BY THE PATIENT THAT FOUR INFUSION SET WAS LEAKING AT 2AM THIS MORNING FROM THE SITE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19402436 ↗MalfunctionMay 27, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE CANADA. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT FOUR INFUSION SET WAS LEAKING AT 2AM THIS MORNING FROM THE SITE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19402435 ↗MalfunctionMay 27, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE CANADA. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT FOUR INFUSION SET WAS LEAKING AT 2AM THIS MORNING FROM THE SITE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19402434 ↗MalfunctionMay 27, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE CANADA ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT FOUR INFUSION SET WAS LEAKING AT 2AM THIS MORNING FROM THE SITE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19402433 ↗MalfunctionMay 23, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SET LEAKING FROM SITE ON (B)(6) 2024. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19379104 ↗MalfunctionMay 23, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SET LEAKING FROM SITE ON (B)(6) 2024 NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19379103 ↗MalfunctionMay 23, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SET LEAKING FROM SITE ON (B)(6) 2024 NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19379102 ↗MalfunctionMay 19, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE CANADA. ON 17 APR 2024, IT WAS REPORTED THAT SIX OUT OF TEN INFUSION SETS HAVE FAILED TO LAST LESS THAN A DAY DUE TO LEAKAGE. INFUSION SETS HAVE BEEN IN USE FOR HOURS NOT FOR A COMPLETE DAY. THE SETS HAVE BEEN LEAKING OUT FROM THE BOTTOM THAT CLIPS TO THE PUMP AND THE PATIENT STATES THE TUBING DID NOT COME APART. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19348403 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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