MioRecalls & reported problems across all models

We found 16 models of Mio by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 394 adverse event reports in the FDA's MAUDE database, received between Feb 12, 2018 and Aug 26, 2026 — classified as 3 deaths, 127 injuries, 264 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (250 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 Mio problems

Mio models

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

• Mio® MMT-975

  Set, Administration, Intravascular
  1 death99 reports
• Mio® MMT-943

  Set, Administration, Intravascular
  1 death96 reports
• Mio® MMT-923

  Set, Administration, Intravascular
  54 reports
• Mio® MMT-941

  Set, Administration, Intravascular
  29 reports
• Mio® MMT-965

  Set, Administration, Intravascular
  28 reports
• Mio® MMT-945

  Set, Administration, Intravascular
  17 reports
• Mio® MMT-925

  Set, Administration, Intravascular
  16 reports
• Mio® MMT-943600

  Set, Administration, Intravascular
  14 reports
• Mio® MMT-921

  Set, Administration, Intravascular
  9 reports
• Mio® MMT-921600

  Set, Administration, Intravascular
  7 reports
• Mio® MMT-941600

  Set, Administration, Intravascular
  1 death5 reports
• Mio® MMT-923600

  Set, Administration, Intravascular
  5 reports
• Mio® MMT-965600

  Set, Administration, Intravascular
  5 reports
• Mio® MMT-975600

  Set, Administration, Intravascular
  4 reports
• Mio® MMT-975T

  Set, Administration, Intravascular
  4 reports
• Mio® MMT-943T

  Set, Administration, Intravascular
  2 reports

Recent Mio adverse event reports

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

• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient faced insulin flow blocked alarm event on (b)(6) 2024 and patient experienced low BG (24mg/dl) and treated with Intravenous glucose treatment.

  Patient problems: Hypoglycemia

  MAUDE report 50450612 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was hospitalized for seven days due to high blood glucose on (b)(6) 2026 and was addressed by intravenous insulin drip.

  Patient problems: Hyperglycemia

  MAUDE report 50344839 ↗
• MalfunctionAug 17, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268952 ↗
• DeathJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS PASSED AWAY DUE TO AN UNKNOWN REASON ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481980 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA AND MANAGED IT BY TAKING SUGAR ON (B)(6) 2026.

  Patient problems: Hypoglycemia

  MAUDE report 24812711 ↗
• 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 LEAK WITH MULTIPLE INFUSION SET ON (B)(6) 2023.THE INSERTION SITE WAS ABDOMEN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709444 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAK WITH MULTIPLE INFUSION SET ON (B)(6) 2023.THE INSERTION SITE WAS ABDOMEN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709428 ↗
• InjuryNov 14, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON 13-OCT DUE TO HIGH BLOOD GLUCISE LEVEL AND REPORTED ISSUE WITH THE PUMP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 20682539 ↗
• MalfunctionNov 7, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKING AT QUICK RELEASE EVENT ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 1 DAY. BLOOD GLUCOSE LEVELS REPORTED DURING THE EVENT WAS 600 MG/DL. THE PATIENT WAS HOSPITALIZED FOR LESS THAN 24 HOURS DUE TO HIGH BLOOD GLUCOSE. PATIENT WAS TREATED WITH INTRAVENOUS INSULIN DRIP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 20631548 ↗
• MalfunctionSep 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE PATIENT FACED OCCLUSION IN THE TUBING EVENT ON 03-AUG-2024. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154135 ↗
• InjuryJul 26, 2024No Apparent Adverse Event; No Apparent Adverse Event

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 25-JUNE-2024, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. THE PATIENT BLOOD GLUCOSE LEVELS AT TIME OF HOSPITALIZATION WERE 20 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 19835570 ↗
• MalfunctionJul 21, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TAP NOT STICKING EVENT ON 19-SEP-2019. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19788897 ↗
• MalfunctionJul 20, 2024Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCK ALARM AND INSULIN DID NOT EXIT TUBING DURING PRIMING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19786639 ↗
• MalfunctionJul 20, 2024Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO BENT CANNULA WHICH RESULTED IN HIGH BG 400 MG/DL. A CORRECTION BOLUS WAS ADMINISTERED WITH QUICK BG RECOVERY NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19786593 ↗
• InjuryJul 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT 33 YEAR OLD MALE PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT. THE TUBING HAD DISCONNECTED FROM INFUSION SET WHICH CAUSED SEVERE HYPERGLYCEMIA. PATIENT EXPERIENCED NAUSEA AND KETONE LEVELS WERE 0.4 MMOL/L AT THE TIME OF EVENT. PATIENT TOOK MANUAL INJECTION TO ADDRESS THE EVENT AND REPLACED INFUSION SET AND RECOVERED PROMPTLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19786340 ↗

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